tDCS for Spinal Cord Injury

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Burke Medical Research Institute

Disqualifiers: Seizures, Pacemaker, Head trauma, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 19

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how combining non-invasive brain stimulation, known as transcranial direct current stimulation (tDCS), with robotic training can enhance abilities in people with spinal cord injuries. The goal is to determine if adding tDCS can amplify the effects of robotic training on movement in those facing ongoing challenges after a spinal cord injury. Participants will receive either active tDCS or a sham (inactive) version to compare outcomes. Suitable candidates have a spinal cord injury affecting hand movement that occurred over six months ago. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe and easy to use. This non-invasive brain stimulation method offers a simple option for treating various conditions, including spinal cord injuries. Most participants in previous studies tolerated it well, experiencing only minor side effects.

One study found that tDCS relieved pain, with improvements observed immediately after treatment. Another study suggested that tDCS might also enhance leg movement in individuals with spinal cord injuries. Overall, tDCS has been used safely in many situations, and strong evidence supports its safety and ease of use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Direct Current Stimulation (tDCS) is unique because it offers a non-invasive way to potentially enhance recovery for individuals with spinal cord injuries. Unlike traditional treatments that primarily focus on physical rehabilitation, tDCS targets the brain's primary motor cortex, applying a mild electrical current to boost neural activity and improve motor function. Researchers are excited about tDCS because it could complement existing therapies by priming the brain for better response to training, offering a promising new avenue for enhancing mobility and independence in affected individuals.

What evidence suggests that tDCS is effective for spinal cord injury rehabilitation?

Research has shown that transcranial direct current stimulation (tDCS) can help individuals with spinal cord injuries regain movement. This technique uses a small electric current to enhance communication between the brain and spinal cord. In this trial, participants will be assigned to either an active tDCS group, receiving 20 minutes of 2 mA stimulation, or a sham tDCS group, receiving a placebo treatment. Previous studies found that more than half of the participants experienced a significant decrease in pain after several tDCS sessions. Additionally, tDCS has been found to aid the brain in adapting and changing, which is crucial for recovery. Overall, these findings suggest that tDCS could effectively improve rehabilitation for those with spinal cord injuries. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

The injury is more than 6 months old.

You have paralysis in your arms and hands, but you are still able to pick up at least one block in a specific test.

You have some movement ability, but not a complete range of motion.

Exclusion Criteria

Medically unstable

You have a complete loss of movement and feeling in a specific part of your body.

You have a history of seizures or have metal objects inside your head.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6-week hand robotic training preceded by 20 min anodal 2mA tDCS or sham, 3 sessions per week, totaling 18 sessions

6 weeks

18 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations conducted a month later

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

How Is the Trial Designed?

Group I: Active tDCS Experimental Treatment 1 Intervention

Participants in this arm will receive 20 minutes of 2 mA transcranial direct current stimulation over the primary motor cortex of the more affected arm prior to robotic training.

Group II: Sham tDCS Placebo Group 1 Intervention

Participants in this arm will receive 20 minutes of sham transcranial direct current stimulation over the primary motor cortex of the more affected arm prior to robotic training.

Who Is Running the Clinical Trial?

Burke Medical Research Institute

Lead Sponsor

Trials

24

Recruited

1,500+

New York State Spinal Cord Injury Research Board (SCIRB)

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

Anodal transcranial direct current stimulation (a-tDCS) at 2 mA significantly increased corticospinal excitability in wrist extensor muscles of individuals with chronic spinal cord injury, with a 40% increase in motor-evoked potential amplitude, while 1 mA and sham stimulation did not show this effect.

Both 1 mA and 2 mA a-tDCS improved sensory perception without any reported adverse effects, indicating that a-tDCS is a safe and effective intervention for enhancing muscle activation and sensory thresholds in patients with spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity dependent effects of transcranial direct current stimulation on corticospinal excitability in chronic spinal cord injury. Murray, LM., Edwards, DJ., Ruffini, G., et al.[2022]

Transcranial direct current stimulation (tDCS) has been found to be safe for use in humans, with no severe complications reported in studies involving both adults and children when applied at intensities of 4 mA or less for up to 60 minutes.

Animal studies indicate that the electrical current used in tDCS is significantly lower than the threshold that could cause permanent changes to brain tissue, suggesting a strong safety profile for this neurorehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. Ko, MH.[2023]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26193817/

Effectiveness of transcranial direct current stimulation for ...

Meta-analytic results indicate a moderate effect of tDCS in reducing neuropathic pain among individuals with SCI; however, the effect was not maintained at ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2214751925000556

The effects of transcranial direct current stimulation on ...

Fregni demonstrated over 50 % reduction in initial pain scores after 5 sessions of anodal M1 tDCS for neuropathic pain due to spinal cord injury [6].

3.

nature.com

nature.com/articles/s41598-024-69127-7

Neuromodulation with transcranial direct current ...

Neuromodulation with transcranial direct current stimulation contributes to motor function recovery via microglia in spinal cord injury | ...

4.

epain.org

epain.org/journal/view.html?uid=1917&vmd=Full

Effects of Transcranial Direct Current Stimulation on pain ...

Conclusions: Our findings suggest that tDCS might be effective for fibromyalgia, migraine, and neuropathic pain associated with spinal cord ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8019961/

Transcranial direct current stimulation for spinal cord injury ...

Several-minute stimulation of the transcranial electric current results in a polarity-dependent induction of glutamatergic calcium-dependent neuroplasticity, ...

6.

nature.com

nature.com/articles/s41393-022-00768-z

Safety and efficacy of transcranial direct current stimulation ...

The purpose of this clinical trial is to evaluate the safety, feasibility and efficacy of pairing noninvasive transcranial direct current stimulation (tDCS) ...

7.

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 ...

8.

jneuroengrehab.biomedcentral.com

jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01129-4

Effects of non-invasive brain stimulation on motor function ...

NIBS appears to positively affect the motor function of the lower extremities in SCI patients, despite the marginal P-value and the high heterogeneity.