Spinal Cord Stimulation for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
Overseen ByEmily Fox, DPT, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Florida
Must not be taking: Botox
Disqualifiers: Multiple sclerosis, Parkinson's, Stroke, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Locomotor training (LT) facilitates recovery of spinal locomotor networks after incomplete spinal cord injury (ISCI), but walking impairments persist. A limitation of LT is insufficient excitation of spinal locomotor circuits to induce neuroplastic recovery. Transcutaneous spinal direct current stimulation (tsDCS) is a non-invasive approach to increase spinal excitation and modulate spinal reflexes. The study will examine if tsDCS combined with LT enhances locomotor rehabilitation after ISCI.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for spinal cord injury?
Research shows that transcutaneous spinal direct current stimulation (tsDCS) can modulate spinal cord activity and improve certain functions in people with incomplete spinal cord injury, such as walking ability and muscle control. Additionally, tsDCS has been shown to affect pain pathways and spinal excitability, which may contribute to its effectiveness.
12345Is transcutaneous spinal direct current stimulation (tsDCS) safe for humans?
Research indicates that transcutaneous spinal direct current stimulation (tsDCS) is a safe technique for modulating spinal cord excitability in humans.
12346How is the treatment tsDCS unique for spinal cord injury?
Transcutaneous spinal direct current stimulation (tsDCS) is unique because it is a non-invasive treatment that uses weak electrical currents to stimulate the spinal cord, potentially improving movement and reducing spasticity in people with spinal cord injuries. Unlike other treatments, tsDCS can modulate spinal cord excitability and pain pathways without the need for surgery or medication.
12345Eligibility Criteria
This trial is for adults aged 18-65 with a chronic spinal cord injury at T12 or above, who can walk 3 meters with assistance. They must be medically stable and able to consent. Excluded are those with skin wounds, severe spasticity, pregnancy, unstable conditions like heart disease, cognitive impairments, other neurological disorders, joint contractures that limit walking ability, visual impairment preventing safe participation in rehabilitation activities.Inclusion Criteria
I am between 18 and 65 years old.
Ability to provide informed consent
Medical stability with clearance from physician
+2 more
Exclusion Criteria
I am currently in a program to improve my walking.
My pain restricts my ability to walk or join in walking rehab.
I am legally blind or have severe vision problems.
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 20 sessions of transcutaneous spinal direct current stimulation (tsDCS) combined with locomotor training (LT) over 5 weeks
5 weeks
20 visits (in-person)
Post-intervention Assessment
Clinical assessments of walking function and reflex testing are completed one to three days post-intervention
1 week
Follow-up
Participants are monitored for safety and effectiveness after treatment with a follow-up assessment of walking and mobility function
2 weeks
1 visit (in-person)
Participant Groups
The AMPLIFY Study tests whether adding transcutaneous spinal direct current stimulation (tsDCS) to locomotor training helps improve walking after an incomplete spinal cord injury. Participants will receive either a high dose or low dose of tsDCS while undergoing walking rehabilitation exercises.
2Treatment groups
Experimental Treatment
Active Control
Group I: High Dose InterventionExperimental Treatment1 Intervention
tsDCS will be delivered to the lumbar region of the spinal cord during LT using a commercially available stimulation unit (Soterix Medical, Inc., New York, NY). tsDCS electrodes are comprised of a 10x5 cm carbon rubber electrode encased in a saline-soaked sponge. The anode electrode will be placed on the skin over the spinal processes of the 11th and 12th thoracic vertebrae, and the two cathode electrodes will be placed on each side of the umbilicus. For the high dose group, a standard dosage of 30 continuous minutes of 2.5 mA stimulus will be used.
Group II: Low Dose InterventionActive Control1 Intervention
tsDCS will be delivered to the lumbar region of the spinal cord during LT using a commercially available stimulation unit (Soterix Medical, Inc., New York, NY). tsDCS electrodes are comprised of a 10x5 cm carbon rubber electrode encased in a saline-soaked sponge. The anode electrode will be placed on the skin over the spinal processes of the 11th and 12th thoracic vertebrae, and the two cathode electrodes will be placed on each side of the umbilicus. The low dose condition will use an identical montage and stimulation arrangement, except the stimulation will be delivered briefly at the beginning and end of the stimulation period (30 seconds) with a three-second ramp.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brooks Rehabilitation HospitalJacksonville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
Brooks RehabilitationCollaborator
The Craig H. Neilsen FoundationCollaborator
References
An unexpected target of spinal direct current stimulation: Interhemispheric connectivity in humans. [2022]Transcutaneous spinal Direct Current Stimulation (tsDCS) is a noninvasive technique based on the application of weak electrical currents over spinal cord.
Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021]Transcutaneous spinal direct current stimulation (tsDCS) is a non-invasive method of stimulating spinal circuits that can modulate and induce changes in corticospinal excitability (CE) in incomplete spinal cord injury (SCI). A double-blinded sham controlled study of 2 male patients (A and B) with SCI was carried out. Patient A received sham and cathodal tsDCS, while Patient B received sham and anodal tsDCS. Four baselines were recorded prior to each arm of stimulation. Outcomes were then measured post each arm of stimulation; 10-meter walk test, modified ashworth scale, berg balance scale, manual muscle testing, and spinal cord independence measure-III. Transcranial magnetic stimulation, assessed motor evoked potentials. Cathodal tsDCS increased the scores in few of the outcome measures and decreased others. Anodal stimulation increased scores in all measures. Motor evoked potentials increased in post-cathode and deteriorated in post-anode. In conclusion, tsDCS modulated gait parameters, spasticity, and CE in incomplete SCI.
Modulation of temporal summation threshold of the nociceptive withdrawal reflex by transcutaneous spinal direct current stimulation in humans. [2017]Transcutaneous spinal direct current stimulation (tsDCS) modulates spinal cord pain pathways. The study is aimed to clarify the neurophysiology of the tsDCS-induced modulation of the spinal cord pain processing by evaluating the effect of the tsDCS on temporal summation threshold (TST) of the nociceptive withdrawal reflex (NWR).
Spinal Direct Current Stimulation Modulates Short Intracortical Inhibition. [2022]Transcutaneous spinal direct current stimulation (tsDCS) is a new and safe technique for modulating spinal cord excitability. We assessed changes in intracortical excitability following tsDCS by evaluating changes in cortical silent period (cSP), paired-pulse short intracortical inhibition (SICI), and intracortical facilitation (ICF).
Effects of transcutaneous spinal direct current stimulation in idiopathic restless legs patients. [2018]Transcutaneous spinal direct current stimulation (tsDCS) is a new non-invasive technique to modulate spinal cord activity. The pathophysiological concept of primary RLS proposes increased spinal excitability.
Trans-Spinal Direct Current Stimulation in Neurological Disorders: A systematic review. [2023]Trans-spinal direct current stimulation (tsDCS) is a noninvasive stimulation technique that applies direct current stimulation over spinal levels. However, the effectiveness and feasibility of this stimulation are still unclear. This systematic review summarizes the effectiveness of tsDCS in clinical and neurophysiological outcomes in neurological patients, as well as its feasibility and safety.