Electrical Stimulation for Tremor
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Shirley Ryan AbilityLab
Disqualifiers: Neurological diseases, Parkinsonism, Epilepsy, Stroke, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to understand the acute, short-term and long-term impact of transcutaneous and/or percutaneous electrical stimulation with afferent-specific electrical stimulation (asES) on proprioception and fine motor control in the upper extremity. For this purpose, the researchers will use transcutaneous and/or percutaneous asES, high-density electromyography (HD-EMG), arm kinematic measurements, and standardized clinical assessments. This study will be conducted in healthy able-bodied individuals and patients with essential tremor (ET).
Will I have to stop taking my current medications?
The trial requires that ET patients have stable medication doses for at least 30 days before joining and throughout the study, so you should not stop taking your current medications.
What data supports the effectiveness of the treatment Sensory Electrical Stimulation for tremor?
Research on Sensory Electrical Stimulation (SES) in stroke patients shows that it can improve movement and function, such as walking speed and hand movement, by stimulating the senses. While this research is focused on stroke recovery, it suggests that SES might help with other movement-related issues, like tremors, by enhancing motor function.
12345Is electrical stimulation safe for treating tremors?
Research suggests that non-invasive electrical stimulation of peripheral nerves is generally safe for managing tremors, with one specific therapy cleared for prescription and home use. This method avoids the side effects of medications and the risks of surgery, making it a promising option for tremor management.
678910How does electrical stimulation for tremor differ from other treatments?
Electrical stimulation for tremor is unique because it uses non-invasive or minimally invasive techniques to stimulate nerves or muscles, reducing tremor without the side effects of medication or the risks of surgery. This approach can provide both immediate and prolonged relief from tremors by targeting specific neural pathways, making it a promising alternative to traditional treatments.
69111213Eligibility Criteria
This trial is for adults aged 18-80 with essential tremor (ET) and healthy individuals without tremors. ET patients must have a moderate-severe wrist tremor, no skull lesions or history of significant head trauma, stable medication doses, and normal hearing/vision. Healthy participants need normal neurological function and cannot be pregnant or have a history of substance abuse.Inclusion Criteria
I have been diagnosed with Essential Tremor by a doctor.
I do not have tremors.
I am between 18 and 80 years old.
+12 more
Exclusion Criteria
I have had brain surgery before.
Healthy Participants: Tremors (as determined by study team)
Healthy Participants: Prisoners
+23 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive transcutaneous or percutaneous afferent-specific electrical stimulation to study its effects on proprioception and fine motor control
1 visit
1 visit (in-person)
Follow-up
Participants are monitored for acute, short-term, and long-term effects of the stimulation on proprioception and fine motor control
24 hours
Participant Groups
The study tests the effects of sensory electrical stimulation on proprioception (sense of body position) and motor control in people with ET and healthy controls. It involves non-invasive electrical stimulation strategies, muscle activity recording (HD-EMG), arm movement tracking, and clinical assessments.
2Treatment groups
Experimental Treatment
Group I: Transcutaneous asESExperimental Treatment2 Interventions
Participants will be administered transcutaneous afferent-specific electrical stimulation in the upper limb using conductive pads targeting the median and radial nerves at the wrist
Group II: Percutaneous asESExperimental Treatment2 Interventions
Participants will be administered percutaneous afferent-specific electrical stimulation in the upper limb using intramuscular leads targeting the flexor and extensor muscles of the wrist
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Shirley Ryan AbilityLabChicago, IL
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Who Is Running the Clinical Trial?
Shirley Ryan AbilityLabLead Sponsor
References
Improving arm function in chronic stroke: a pilot study of sensory amplitude electrical stimulation via glove electrode during task-specific training. [2022]To investigate the effects of sensory amplitude electrical stimulation (SES) delivered by glove electrode during task-specific exercise on arm movement, function, and sensation in chronic stroke.
Effects of repetitive electrical stimulation to treat sensory loss in persons poststroke. [2016]Smith PS, Dinse HR, Kalisch T, Johnson M, Walker-Batson D. Effects of repetitive electrical stimulation to treat sensory loss in persons poststroke.
Sensory Amplitude Electrical Stimulation via Sock Combined With Standing and Mobility Activities Improves Walking Speed in Individuals With Chronic Stroke: A Pilot Study. [2020]Objective: To determine if sensory amplitude electrical stimulation (SES) delivered via sock electrode combined with standing and mobility activities improved gait speed, sensation, balance, and participation in chronic stroke. It was hypothesized that SES would enhance the effectiveness of exercise, resulting in reduced impairment and improved function. Design: Case Series. Setting: Home-based intervention. Participants: Thirteen adults (56.5 + 7.84 years old) with chronic stroke (8.21 + 4.36 years post) and hemiparesis completed the study. Participants were community ambulators. Intervention: Participants completed 6 weeks of self-administered SES delivered via sock electrode concurrent with standing and mobility activities for a minimum of 5 days/week for 30-min, twice daily. Outcome Measures: Berg Balance Scale (BBS), Stroke Rehabilitation Assessment of Movement-LE subscale (STREAM), 10 Meter Walk Test (10 MWT), Activities-Specific Balance Confidence Scale (ABC), Stroke Impact Scale (SIS), Perceptual Threshold of Electrical Stimulation (PTTES), and Monofilament testing were administered at pre-test, post-test, and 3-month follow up. Results: Baseline sensory scores and change scores on functional outcomes were analyzed using Pearson Product-Movement Correlation Coefficients, Friedman test, and Linear mixed models. There was a significant change with 10 MWT self-selected pace (Friedman's p = 0.038). Pre-post intervention changes in other outcome measures were not significant. According to the Cohen's effect size classification, there were medium effect sizes for both the STREAM-LE and Monofilaments. Conclusion: The use of home-based SES via sock electrode combined with standing and mobility activities may contribute to improve gait speed in chronic stroke.
Somatosensory stimulation to improve hand and upper limb function after stroke-a systematic review with meta-analyses. [2018]Background Somatosensory stimulation may have a positive impact on recovery of motor function by maintaining cortical representation of the hand and acting to prime the motor system for movement. Objective Determine the efficacy of somatosensory stimulation on upper limb motor function after stroke. Methods Five electronic databases (MEDLINE, CINAHL, Embase, PEDro and OT Seeker) were searched from inception to October 2016. Included studies were English-language randomized controlled trials where a sensory intervention was applied below the elbow to improve upper limb motor control of adults after stroke. One outcome needed to measure arm function at an impairment or activity level. Study selection and quality assessment (using the PEDro scale) were independently conducted by two reviewers. Meta-analysis was completed where there was sufficient homogeneity between trials. Results Fifteen articles were included reporting data from 14 randomized controlled trials (627 participants). There was low-quality evidence from four trials that sensory electrical stimulation did not improve upper limb activity compared to placebo (SMD 0.4, 95%CI -0.07 to 0.87, I2 38%) and moderate-quality evidence from three trials that it did not improve motor impairment (MD 3.45 units, 95%CI -1.47 to 8.36, I2 35%). Low-quality evidence from two trials demonstrated that therapist-delivered sensory stimulation did not improve upper limb activity (SMD 0.25, 95%CI -0.20 to 0.69, I2 0%) compared to usual care. Conclusion Current low- to moderate-quality evidence suggests somatosensory stimulation is not effective in improving upper limb motor impairment or activity after stroke.
Electrical somatosensory stimulation improves movement kinematics of the affected hand following stroke. [2017]The effect of electrical somatosensory stimulation on motor performance of the affected hand was investigated in 12 chronic subcortical stroke subjects.
Sensory electrical stimulation for suppression of postural tremor in patients with essential tremor. [2015]Essential tremor is an involuntary trembling of body limbs in people without tremor-related disease. In previous study, suppression of tremor by sensory electrical stimulation was confirmed on the index finger. This study investigates the effect of sensory stimulation on multiple segments and joints of the upper limb. It denotes the observation regarding the effect's continuity after halting the stimulation. 18 patients with essential tremor (8 men and 10 women) participated in this study. The task, "arms stretched forward", was performed and sensory electrical stimulation was applied on four muscles of the upper limb (Flexor Carpi Radialis, Extensor Carpi Radialis, Biceps Brachii, and Triceps Brachii) for 15 seconds. Three 3-D gyro sensors were used to measure the angular velocities of segments (finger, hand, and forearm) and joints (metacarpophalangeal and wrist joints) for three phases of pre-stimulation (Pre), during-stimulation (On), and 5 minute post-stimulation (P5). Three characteristic variables of root-mean-squared angular velocity, peak power, and peak power frequency were derived from the vector sum of the sensor signals. At On phase, RMS velocity was reduced from Pre in all segments and joints while peak power was reduced from Pre in all segments and joints except for forearm segment. Sensory stimulation showed no effect on peak power frequency. All variables at P5 were similar to those at On at all segments and joints. The decrease of peak power of the index finger was noted by 90% during stimulation from that of On phase, which was maintained even after 5 min. The results indicate that sensory stimulation may be an effective clinical method to treat the essential tremor.
Safety considerations for deep brain stimulation: review and analysis. [2007]Deep brain stimulation has emerged rapidly as an effective therapy for movement disorders. Deep brain stimulation includes an implanted brain electrode and a pacemaker-like implanted pulse generator. The clinical application of deep brain stimulation proceeded in the absence of clear understandings of its mechanisms of action or extensive preclinical studies of safety and efficacy. Post mortem studies suggest that there is a loss of neurons in proximity to the active electrode, but the resulting lesions are not sufficient to treat the disorder and efficacy requires continued stimulation. Overall complication rates can exceed 25%, and permanent neurologic sequelae result in 4-6% of cases. As the application of deep brain stimulation expands, it is critical to understand the origin of adverse events and the delivery of nondamaging stimulation.
Dual channel deep brain stimulation system (Kinetra) for Parkinson's disease and essential tremor: a prospective multicentre open label clinical study. [2019]To evaluate the safety and efficacy of a new dual channel stimulator (Kinetra) in patients with severe Parkinson's disease (PD) or essential tremor (ET).
Non-invasive electrical stimulation of peripheral nerves for the management of tremor. [2023]Pathological tremor in patients with essential tremor and Parkinsons disease is typically treated using medication or neurosurgical interventions. There is a widely recognized need for new treatments that avoid the side effects of current medications and do not carry the risks of surgical interventions. Building on decades of research and engineering development, non-invasive electrical stimulation of peripheral nerves has emerged as a safe and effective strategy for reducing pathologic tremor in essential tremor. This review surveys the peripheral electrical stimulation (PES) literature and summarizes effectiveness, safety, clinical translatability, and hypothesized tremor-reduction mechanisms of various PES approaches. The review also proposes guidelines for assessing tremor in the context of evaluating new therapies that combine the strengths of clinician assessments, patient evaluations, and novel motion sensing technology. The review concludes with a summary of future directions for PES, including expanding clinical access for patients with Parkinson's disease and leveraging large, at-home datasets to learn more about tremor physiology and treatment effect that will better characterize the state of tremor management and accelerate discovery of new therapies. Growing evidence suggests that non-invasive electrical stimulation of afferent neural pathways provides a viable new option for management of pathological tremor, with one specific PES therapy cleared for prescription and home use, suggesting that PES be considered along with medication and neurosurgical interventions for treatment of tremor. This article is part of the Special Issue "Tremor" edited by Daniel D. Truong, Mark Hallett, and Aasef Shaikh.
Augmented visual feedback counteracts the effects of surface muscular functional electrical stimulation on physiological tremor. [2021]Recent studies suggest that surface muscular functional electrical stimulation (FES) might suppress neurological upper limb tremor. We assessed its effects on upper limb physiological tremor, which is mainly driven by mechanical-reflex oscillations. We investigated the interaction between FES and augmented visual feedback, since (a) most daily activities are performed using visual cues, and (b) augmented visual feedback exacerbates upper limb tremor.
Intramuscular Stimulation of Muscle Afferents Attains Prolonged Tremor Reduction in Essential Tremor Patients. [2021]This study proposes and clinically tests intramuscular electrical stimulation below motor threshold to achieve prolonged reduction of wrist flexion/extension tremor in Essential Tremor (ET) patients. The developed system consisted of an intramuscular thin-film electrode structure that included both stimulation and electromyography (EMG) recording electrodes, and a control algorithm for the timing of intramuscular stimulation based on EMG (closed-loop stimulation). Data were recorded from nine ET patients with wrist flexion/extension tremor recruited from the Gregorio Marañón Hospital (Madrid, Spain). Patients participated in two experimental sessions comprising: 1) sensory stimulation of wrist flexors/extensors via thin-film multichannel intramuscular electrodes; and 2) surface stimulation of the nerves innervating the same target muscles. For each session, four of these patients underwent random 60-s trials of two stimulation strategies for each target muscle: 1) selective and adaptive timely stimulation (SATS) - based on EMG of the antagonist muscle; and 2) continuous stimulation (CON) of target muscles. Two patients underwent SATS stimulation trials alone while the other three underwent CON stimulation trials alone in each session. Kinematics of wrist, elbow, and shoulder, together with clinical scales, were used to assess tremor before, right after, and 24 h after each session. Intramuscular SATS achieved, on average, 32% acute (during stimulation) tremor reduction on each trial, while continuous stimulation augmented tremorgenic activity. Furthermore, tremor reduction was significantly higher using intramuscular than surface stimulation. Prolonged reduction of tremor amplitude (24 h after the experiment) was observed in four patients. These results showed acute and prolonged (24 h) tremor reduction using a minimally invasive neurostimulation technology based on SATS of primary sensory afferents of wrist muscles. This strategy might open the possibility of an alternative therapeutic approach for ET patients.
Somatosensory evoked potentials in the ventrolateral thalamus. [2019]Within the target area (VL) used for the stereotactic treatment of parkinsonian tremor and spasmodic torticollis, electrical stimulation as well as recording of somatosensory evoked potential (SEP) was performed. The effects of stimulation in the target area are facilitation of muscle tone showing some degree of somatotopic distribution. The recorded SEPs indicate a projection of an afferent system (probably of muscle afferents) to the target area. We assume that the target area is a relay station involved in the control of muscle tone. The interruption of muscle afferents in combination with the correct somatotopic localization of the lesion is important for the therapeutic efficacy in parkinsonian tremor and spasmodic torticollis.
Development of a closed-loop system for tremor suppression in patients with Parkinson's disease. [2020]More than 70% of patients suffering Parkinson's disease (PD) exhibit resting tremor in their extremities, hampering their ability to perform daily activities. Based on our earlier studies on corticospinal transmission of tremor signals [10,11], we hypothesize that cutaneous afferents evoked by surface stimulation can produce an inhibitory effect on propriospinal neurons (PN), which in turn will suppress tremor signals passing through the PN. This paper presents the development of a closed-loop system for tremor suppression by transcutaneous electrical nerve stimulation (TENS) of sensory fibers beneath the skin. The closed-loop system senses EMGs of forearm muscles, and detects rhythmic bursting in the EMG signal. When a tremor is detected by the system, a command signal triggers a stimulator to output a train of bi-phasic, current regulated pulses to a pair of surface electrodes. The stimulation electrode is placed on the dorsal hand skin near the metacarpophalangeal joint of index finger, which is innervated by the superficial radial nerve that projects an inhibitory afferent to PNs of forearm muscles. We tested the closed-loop system in 3 normal subjects to verify the algorithm and in 2 tremor dominated PD subjects for feasibility of tremor detecting and suppression. Preliminary results indicate that the closed-loop system can detect tremor in all subjects, and tremor in PD patients was suppressed significantly by electrical stimulation of cutaneous afferents.