Spinal Cord Stimulation for Spinal Cord Injury

Overseen By Emily Fox, PT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Botox

Disqualifiers: Multiple sclerosis, Parkinson's, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: 5 weeks

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a non-invasive treatment called transcutaneous spinal direct current stimulation (tsDCS) can enhance walking recovery in people with incomplete spinal cord injuries. Participants will undergo locomotor training combined with either a high or low dose of tsDCS to stimulate spinal reflexes, potentially improving their walking ability. Ideal candidates have had a single spinal cord injury for over a year and can walk a short distance, even if they need assistance or equipment.

As an unphased trial, participants can contribute to groundbreaking research that could improve rehabilitation methods for spinal cord injuries.

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 prior data suggests that transcutaneous spinal direct current stimulation is safe for spinal cord injury rehabilitation?

Research has shown that transcutaneous spinal direct current stimulation (tsDCS) is generally safe. Participants in studies have tolerated the stimulation well without major issues. Past research using higher doses reported no significant side effects, suggesting relative safety. For the lower dose, evidence indicates it resembles a placebo, implying it is very safe. Studies confirm that no specific spinal-related side effects have been reported with this stimulation. Although safety data for tsDCS is limited, its use in various settings suggests it is a safe and practical method to influence nerve activity. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore a new way to help people with spinal cord injuries. Traditional treatments often focus on rehabilitation exercises and medications to manage symptoms. However, these new interventions use transcutaneous spinal direct current stimulation (tsDCS), which delivers electrical currents to the spinal cord to potentially enhance mobility and recovery. The high dose intervention provides a continuous stimulation, while the low dose offers brief pulses, both aiming to improve nerve function without invasive procedures. This innovative approach could offer a non-invasive option to boost recovery in spinal cord injury patients.

What evidence suggests that transcutaneous spinal direct current stimulation is effective for spinal cord injury?

Research shows that transcutaneous spinal direct current stimulation (tsDCS) can aid people with spinal cord injuries by enhancing movement and reducing pain. This trial will compare two different doses of tsDCS. Participants in the high-dose intervention arm will receive a higher dose of tsDCS, which studies have shown can alter pain perception and improve movement, making it a promising option for rehabilitation. Participants in the low-dose intervention arm will receive a lower dose of tsDCS, considered safe and shown to reduce pain similarly. Overall, combining tsDCS with movement training could be a valuable approach to improving mobility after spinal cord injuries. ^{2 4 6 7 8}

Who Is on the Research Team?

Emily Fox, DPT, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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

Medical stability with clearance from physician

Ability to provide informed consent

I can walk 3 meters by myself or with help.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• High Dose Intervention-tsDCS
• Low Dose Intervention-tsDCS

Trial Overview 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.

How Is the Trial Designed?

Group I: High Dose Intervention Experimental Treatment 1 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 Intervention Active Control 1 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.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Brooks Rehabilitation

Collaborator

Trials

16

Recruited

1,900+

The Craig H. Neilsen Foundation

Collaborator

Trials

62

Recruited

3,100+

Published Research Related to This Trial

Transcutaneous spinal direct current stimulation (tsDCS) is a safe technique that can effectively modulate spinal cord excitability, as shown by changes in motor-evoked potentials (MEPs) in healthy subjects after stimulation.

The study found that cathodal tsDCS increased MEP amplitudes indicating enhanced inhibitory GABA(A)ergic drive, while anodal tsDCS had the opposite effect, suggesting tsDCS could be a promising rehabilitation strategy for patients with acute brain lesions or spinal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Direct Current Stimulation Modulates Short Intracortical Inhibition. Bocci, T., Barloscio, D., Vergari, M., et al.[2022]

Anodal transcutaneous spinal direct current stimulation (tsDCS) significantly increased the temporal summation threshold of the nociceptive withdrawal reflex in 10 healthy subjects, indicating its potential to modulate spinal cord pain pathways.

This stimulation also led to a decrease in the perception of pain, suggesting that anodal tsDCS could be an effective non-invasive treatment for clinical pain conditions related to spinal cord activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of temporal summation threshold of the nociceptive withdrawal reflex by transcutaneous spinal direct current stimulation in humans. Perrotta, A., Bolla, M., Anastasio, MG., et al.[2017]

Trans-spinal direct current stimulation (tsDCS) has shown potential benefits, such as reducing hypertonia and neuropathic pain, particularly with anodal stimulation in patients with central nervous system diseases, based on a review of 8 studies involving 143 subjects.

The application of tsDCS was found to be feasible and safe, with no severe adverse effects reported, although the overall effectiveness remains uncertain due to variability in study results and the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans-Spinal Direct Current Stimulation in Neurological Disorders: A systematic review. Fernández-Pérez, JJ., Serrano-Muñoz, D., Beltran-Alacreu, H., et al.[2023]

In a double-blinded study involving 2 male patients with incomplete spinal cord injury, anodal transcutaneous spinal direct current stimulation (tsDCS) improved all measured outcomes, including gait and balance, while cathodal tsDCS showed mixed results.

Both types of tsDCS were able to modulate corticospinal excitability, indicating that this non-invasive method could be a promising approach for enhancing rehabilitation in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. Abualait, TS., Ibrahim, AI.[2021]

Transcutaneous spinal Direct Current Stimulation (tsDCS) can effectively modulate interhemispheric motor connectivity, with anodal stimulation increasing interhemispheric delay and decreasing the duration of the ipsilateral Silent Period, indicating enhanced communication between brain hemispheres.

The study suggests that tsDCS could serve as a promising therapeutic tool for conditions involving impaired interhemispheric balance, offering a safe alternative for rehabilitation in patients with acute brain lesions when other non-invasive brain stimulation techniques may not be suitable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An unexpected target of spinal direct current stimulation: Interhemispheric connectivity in humans. Bocci, T., Caleo, M., Vannini, B., et al.[2022]

In a pilot study involving 20 patients with idiopathic Restless Legs Syndrome (RLS) and 14 healthy subjects, transcutaneous spinal direct current stimulation (tsDCS) was shown to reduce symptoms of RLS, indicating its potential as a non-invasive treatment option.

Anodal stimulation specifically decreased spinal excitability, as measured by the H2/H1-ratio, and led to significant reductions in RLS symptoms, while sham stimulation had no effect, supporting the idea that spinal cord hyperexcitability contributes to RLS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal direct current stimulation in idiopathic restless legs patients. Heide, AC., Winkler, T., Helms, HJ., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11677310/

Immediate Effects of Distinct Intensities of Transcutaneous ... The results indicate that a single 20-min session of 2 and 0.5 mA tsDCS improves pain scores for both intensities equally. However, there were ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12485468/

Effects of Transcranial Direct Current Stimulation on pain and ... Our findings suggest that tDCS might be effective for fibromyalgia, migraine, and neuropathic pain associated with spinal cord injury and stroke ...

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.695910/full

Effects of Transcutaneous Spinal Direct Current Stimulation ... Conclusions: Our findings suggest that tsDCS could modulate nociceptive processing and pain perception in chronic pain syndromes. Introduction.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590109525001119

Therapeutic Effects of Noninvasive Technology Modalities ... Feasibility of transcutaneous spinal direct current stimulation combined with locomotor training after spinal cord injury. Spinal Cord 2022;60: ...

5. journals.lww.com journals.lww.com/bnam/_layouts/15/oaks.journals/downloadpdf.aspx?an=02273541-202501000-00002

Transcutaneous spinal direct current stimulation for motor ... This review aims to consolidate the current body of evidence on tsDCS and its role in enhancing motor performance in both healthy individuals and patients with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12014404/

Cardiovascular safety of transcutaneous spinal cord ... Further work is required to elucidate potential long-term effects of targeted tSCS on cardiovascular function in people with spinal cord injury.

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/42/NCT03702842/Prot_SAP_000.pdf

Transcutaneous Stimulation to Enhance Walking after ... The higher dosage of tsDCS aligns with previous research protocols, while the lower dosage can be effectively be viewed as sham stimulation. Bilateral lower ...

8. journals.sagepub.com journals.sagepub.com/doi/10.3233/NRE-172369

The effect of transcutaneous spinal direct current ... This study investigated the feasibility of modulating bilateral corticospinal excitability with different polarities of transcutaneous spinal direct current ...