Electrical Stimulation for Paralysis/Paresis
Recruiting in Palo Alto (17 mi)
Overseen byChad E Bouton, MS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Northwell Health
Must not be taking: Botulinum toxin
Disqualifiers: Epilepsy, Implanted devices, Substance abuse, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This is an early feasibility trial to determine whether transcutaneous neuromuscular electrical stimulation, with or without transcutaneous spinal cord stimulation, using an investigational neurostimulation device improves functional arm/hand movements in individuals with paralysis or paresis due to a spinal cord injury or stroke and improves functional arm/hand or leg/foot movements in individuals with paralysis or paresis due to other brain or nerve injuries.
In this study, eligible individuals that agree to participate will be asked to attend up to 5 study sessions a week for 1 year (depending on participant availability), with each session lasting up to 4 hours. At the first study session, participants will have their demographic information collected, vital signs assessed, and have measurements performed of their limbs and torso, as appropriate. They will also undergo clinical evaluations and tests to assess their current functional movement and sensation capabilities.
During subsequent study sessions, participants will undergo many tasks designed to improve functional movements in paralyzed limbs. Specifically, participants will receive neuromuscular electrical stimulation to the limb(s) and/or electrical stimulation to the spinal cord to evoke specified movements. The stimulation parameters and locations on the spinal column and/or limb(s) that evoke specific movements will be noted. The movements will be assessed with visual inspection, electromyography, and/or sensors.
The clinical evaluations and tests to assess functional movement and sensation capabilities will be repeated throughout the study and at the last study session to assess for functional improvements compared to the first study session. Upon completion of these study sessions, the individual's participation in the study is considered complete.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have severe spasticity that is not controlled by medication, it may affect your eligibility.
What data supports the effectiveness of the treatment Transcutaneous Electrical Stimulation for paralysis/paresis?
Research shows that transcutaneous electrical stimulation can help improve muscle strength, motor control, and reduce spasticity (muscle stiffness) in patients with spinal cord injuries and cerebral palsy. It has also been shown to promote long-term recovery of upper extremity function in individuals with chronic spinal cord injuries.
12345Is electrical stimulation safe for humans?
Electrical stimulation methods like transcutaneous electrical muscle stimulation and low-intensity transcranial electrical stimulation are generally considered safe, with good tolerability and no serious adverse events reported in many sessions. However, there is a risk of skin burns if the equipment is not used properly, and mild side effects like headaches and fatigue can occur.
26789How is the treatment of Transcutaneous Electrical Stimulation unique for paralysis/paresis?
Transcutaneous Electrical Stimulation is unique because it uses electrical currents to stimulate muscles and nerves through the skin, helping to improve muscle strength, control, and movement in people with paralysis or weakness. Unlike some other treatments, it can be combined with therapies like exercise or botulinum toxin for added benefits, and it can be tailored to trigger specific muscle movements, aiding in tasks like walking or grasping.
13101112Eligibility Criteria
This trial is for individuals aged 18-75 with paralysis or paresis due to spinal cord injury, stroke, or other brain/nerve injuries. Healthy volunteers without physical disabilities are also eligible. Participants must be English proficient, able to understand the study, and commit to frequent visits over a year.Inclusion Criteria
I am 18-75, healthy, understand English, and can visit the study center.
I am 18-75, with a limb I can't use well due to brain or nerve injury, speak English, and can visit the study center.
I am 18-75, had a stroke or spinal cord injury over a year ago, and struggle to use one hand.
Exclusion Criteria
Individuals participating in another study that may affect the conduct or results of this study
I do not have severe pressure ulcers, epilepsy, implanted devices, or other listed conditions.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Initial assessments including demographic information, vital signs, and functional movement and sensation capabilities
1 session
1 visit (in-person)
Treatment
Participants receive neuromuscular and/or spinal cord stimulation to improve functional movements
12 months
Up to 5 visits per week (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial tests if transcutaneous electrical stimulation improves arm/hand and leg/foot function in paralyzed or weakened limbs. It involves up to five sessions per week for one year with tasks designed to enhance movement through neuromuscular and spinal cord stimulation.
4Treatment groups
Experimental Treatment
Active Control
Group I: Individuals with other Brain or Nerve InjuriesExperimental Treatment1 Intervention
This arm consists of individuals with a other brain and nerve injuries receiving transcutaneous electrical stimulation to the arms/hand, legs/foot, and/or spinal column to evoke various arm/hand or leg/foot movements.
Group II: Individuals with a StrokeExperimental Treatment1 Intervention
This arm consists of individuals with a stroke receiving transcutaneous electrical stimulation to the arms/hand and/or spinal column to evoke various arm/hand movements.
Group III: Individuals with a Spinal Cord InjuryExperimental Treatment1 Intervention
This arm consists of individuals with a spinal cord injury receiving transcutaneous electrical stimulation to the arms/hand and/or spinal column to evoke various arm/hand movements.
Group IV: Healthy VolunteersActive Control1 Intervention
This arm consists of healthy volunteers receiving transcutaneous electrical stimulation to the arms, legs, and/or spinal column to evoke various arm/hand and leg/foot movements.
Transcutaneous Electrical Stimulation is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Transcutaneous Electrical Stimulation for:
- Paralysis or paresis due to spinal cord injury or stroke
- Paralysis or paresis due to other brain or nerve injuries
🇪🇺 Approved in European Union as Transcutaneous Electrical Stimulation for:
- Spinal cord injury rehabilitation
- Neuromuscular rehabilitation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwell Health's The Feinstein Institute for Medical ResearchManhasset, NY
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Who Is Running the Clinical Trial?
Northwell HealthLead Sponsor
References
Non-invasive neuromuscular electrical stimulation in patients with central nervous system lesions: an educational review. [2022]The aim of this educational review is to provide an overview of the clinical application of transcutaneous electrical stimulation of the extremities in patients with upper motor neurone lesions. In general two methods of electrical stimulation can be distinguished: (i) therapeutic electrical stimulation, and (ii) functional electrical stimulation. Therapeutic electrical stimulation improves neuromuscular functional condition by strengthening muscles, increasing motor control, reducing spasticity, decreasing pain and increasing range of motion. Transcutaneous electrical stimulation may be used for neuromuscular electrical stimulation inducing repetitive muscle contraction, electromyography-triggered neuromuscular electrical stimulation, position-triggered electrical stimulation and subsensory or sensory transcutaneous electric stimulation. Functional electrical stimulation provokes muscle contraction and thereby produces a functionally useful movement during stimulation. In patients with spinal cord injuries or stroke, electrical upper limb neuroprostheses are applied to enhance upper limb and hand function, and electrical lower limb neuroprostheses are applied for restoration of standing and walking. For example, a dropped foot stimulator is used to trigger ankle dorsiflexion to restore gait function. A review of the literature and clinical experience of the use of therapeutic electrical stimulation as well as of functional electrical stimulation in combination with botulinum toxin, exercise therapy and/or splinting are presented. Although the evidence is limited we conclude that neuromuscular electrical stimulation in patients with central nervous system lesions can be an effective modality to improve function, and that combination with other treatments has an additive therapeutic effect.
Treatment of spinal spasticity by electrical stimulation. [2019]We present the results and the methodology of trials using transcutaneous electrical stimulation. The aim of our work was to decrease spasticity in 44 patients with traumatic damage to the spinal cord; 35 non-electrically stimulated spastics were used as controls. Both groups were randomly selected from inpatients in the Paraplegic Department at the Hospital Rehabilitation Centre. This electrical stimulation procedure leads to a long-lasting reduction in spasticity, an increased range of passive and active movements, the facilitation of lost functions, an improvement in breathing, an increase in pulmonary capacity, the reappearance of some neurological reflexes, and a diminution of supersensitivity to skin irritation. Blood pressure and neurogenic bladder functions were restored to normal. In addition to clinical observations, we investigated muscle force and the electromyogram; other measurements used in the trials involved the use of a specially adapted neurological hammer, a pendulum test, spirometry, cystometry, sphincterometry and biochemical estimations.
Electrical stimulation for control of paralysis and therapy of abnormal movements. [2006]After a short review of the functional aspects of electrical stimulation in rehabilitating paralysed patients, the article describes its effects on spasticity. Three different studies are briefly described. In the first one paraplegic patients' knee extensors and flexors were stimulated with four channel stimulator. In the second one two channel stimulation was applied to the ankle joint flexors and extensors in hemiplegic patients, while in the third, the effects of spinal cord stimulation were studied in multiple sclerosis patients. Although the parameters and sites of stimulation were different in each study, the effects were similar. In approximately 50% of paraplegic and hemiplegic patients stimulation caused decrease of reflex activity which lasted more than half an hour. In M.S. patients measurements were performed only in intervals of day and therefore short term effects were not documented. Two days after interruption of continuous spinal cord stimulation the reflex activity significantly increased in the majority of patients. In addition to this increase the volitional force decreased considerably.
Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. [2020]Upper extremity function is the highest priority of tetraplegics for improving quality of life. We aim to determine the therapeutic potential of transcutaneous electrical spinal cord stimulation for restoration of upper extremity function. We tested the hypothesis that cervical stimulation can facilitate neuroplasticity that results in long-lasting improvement in motor control. A 62-year-old male with C3, incomplete, chronic spinal cord injury (SCI) participated in the study. The intervention comprised three alternating periods: 1) transcutaneous spinal stimulation combined with physical therapy (PT); 2) identical PT only; and 3) a brief combination of stimulation and PT once again. Following four weeks of combined stimulation and physical therapy training, all of the following outcome measurements improved: the Graded Redefined Assessment of Strength, Sensation, and Prehension test score increased 52 points and upper extremity motor score improved 10 points. Pinch strength increased 2- to 7-fold in left and right hands, respectively. Sensation recovered on trunk dermatomes, and overall neurologic level of injury improved from C3 to C4. Most notably, functional gains persisted for over 3 month follow-up without further treatment. These data suggest that noninvasive electrical stimulation of spinal networks can promote neuroplasticity and long-term recovery following SCI.
Neuromuscular approach to the motor deficits of cerebral palsy: a pilot study. [2006]Six children with mild cerebral palsy (CP) entered a study of overnight low-intensity transcutaneous electrical stimulation (ES) to the leg muscles. After 6 months, statistically significant improvement was noted on the Peabody Developmental Motor Scales scores in gross motor, locomotor, and receipt/propulsion skills. When ES was withdrawn for 6 months, there was uniform loss in scores. Reinstitution of ES resulted in further significant improvements in total gross motor, balance, locomotor, and receipt/propulsion skills. In selected cases, overnight ES may be a useful addition to standard rehabilitation services.
Feasibility of transcutaneous electrical muscle stimulation in acute exacerbation of COPD. [2021]Transcutaneous electrical muscle stimulation is a well-established intervention for rehabilitation of clinically stable patients with chronic obstructive pulmonary disease. This study investigated feasibility and safety of this method during acute exacerbation of chronic obstructive pulmonary disease. We included 19 patients (71 ± 6 years, 76% men) who underwent two sessions/day during hospitalization (15 ± 1 training sessions). They reported good tolerability and excellent safety profile of transcutaneous electrical muscle stimulation. Our results set the stage for future research to determine specific benefit of transcutaneous electrical muscle stimulation, either alone or in combination with nutritional support and pharmacological therapy.
Burns in functional electric stimulation: two case reports. [2004]Electric stimulation of nerve and muscle is a widely used procedure for diagnosis and therapy in spinal cord injured patients. Damage from such stimulation can occur in the form of tissue burns. Two cases of burns in spinal cord patients receiving functional electric stimulation are presented. It is concluded that to avoid burning of tissue: a stimulating electrode with a large surface should be used; uniform contact between the electrode and the skin should be insured; a good conducting-material interface between the electrode and skin is required; adequate ventilation for heat dissipation should be provided; sharply cut electrode corners, wire insulation damage, and cuts in lead wires must be avoided.
Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1-2mA and during tACS at higher peak-to-peak intensities above 2mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity 'conventional' TES defined as <4mA, up to 60min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3-13A/m2 that are over an order of magnitude above those produced by tDCS in humans. Using AC stimulation fewer AEs were reported compared to DC. In specific paradigms with amplitudes of up to 10mA, frequencies in the kHz range appear to be safe. In this paper we provide structured interviews and recommend their use in future controlled studies, in particular when trying to extend the parameters applied. We also discuss recent regulatory issues, reporting practices and ethical issues. These recommendations achieved consensus in a meeting, which took place in Göttingen, Germany, on September 6-7, 2016 and were refined thereafter by email correspondence.
Effects of a fifty-six month electrical stimulation cycling program after tetraplegia: case report. [2018]Functional electrical stimulation cycling is a common clinical treatment for individuals with spinal cord injury and other paralytic conditions, however, the long term effects of home-based functional electrical stimulation cycling remains unreported.
A multi-pad electrode based functional electrical stimulation system for restoration of grasp. [2021]Functional electrical stimulation (FES) applied via transcutaneous electrodes is a common rehabilitation technique for assisting grasp in patients with central nervous system lesions. To improve the stimulation effectiveness of conventional FES, we introduce multi-pad electrodes and a new stimulation paradigm.
Contralaterally-controlled functional electrical stimulation-induced muscle contraction for severe lower extremity paralysis. [2023][Purpose] We describe a new method of functional electrical stimulation therapy for severe hemiparesis. Conventional functional electrical stimulation of the lower legs has limited applications. It is only suitable for patients who can monitor their muscle contractions, and it has complicated equipment installation procedures. [Participant and Methods] The participant was a male in his 40s with severe motor paralysis following brain surgery. We monitored the participant's healthy side using the external assist mode of an Integrated Volitional Control Electrical Stimulation (IVES® OG Giken, Okayama, Japan) system while forcibly contracting the paralyzed side. The participant received this new functional electrical stimulation therapy five times per week. [Results] Two weeks after initiation of therapy, paralysis was noticeably improved, and motor function was maintained for approximately 1 year. [Conclusion] The outcomes of this case suggest that the addition of forced contraction therapy, mirror therapy, and repetitive exercise therapy to regular physical therapy may be beneficial. This treatment method may also be useful in postoperative patients with central motor palsy and no muscle contraction ability.
Upper extremity applications of functional neuromuscular stimulation. [2006]Functional electrical stimulation (FES) has been used for increasing muscle strength, decreasing spasticity, and controlling movement of limbs for many years. Most of this work, however, has been done in a research setting. Over the past decade, FES has moved slowly from the laboratory to the clinical world through feasibility studies in groups of patients with spinal cord injuries and strokes. Electrical stimulation has been shown to decrease spastic tone both during and after the stimulation, allowing for better limb positioning, decrease in contracture formation, and in some cases, improvement of voluntary movement. Electrical stimulation as a motor prosthesis is now being provided to small groups of spinal cord-injured patients (primarily C4, C5 and C6 levels) to assist with hand positioning and to produce hand grasp. In these settings, patients have attained greater independence in activities of daily living and in work-related tasks. Distribution of this technology to multiple centers is continuing through a technology transfer program.