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

13 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses brain stimulation and special exercises to help people with long-term spinal cord injuries improve their hand function. The brain stimulation makes the exercises more effective, potentially leading to better outcomes. Advances in technology have helped improve abilities in spinal cord injury survivors, and combining brain stimulation with exercise therapy has shown promise in improving hand function.

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 the treatment Transcranial Direct Current Stimulation (tDCS) for spinal cord injury?

Research shows that tDCS can help improve hand and arm functions and reduce pain in people with spinal cord injuries. It works by stimulating the brain to enhance muscle control and reduce pain signals. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

tDCS is generally considered safe for humans, with mild and temporary side effects like itching and tingling. Studies show no serious or lasting harm when used at standard levels (up to 4 milliamperes for 40 minutes) across many sessions and participants, including vulnerable groups. ^{6 7 8 9 10}

How does the tDCS treatment for spinal cord injury differ from other treatments?

Transcranial direct current stimulation (tDCS) is unique because it is a noninvasive technique that uses electrical currents to stimulate the brain, specifically the primary motor cortex, to potentially improve motor function and manage pain in spinal cord injury patients. Unlike traditional treatments, tDCS is applied externally and may offer benefits in muscle activation, hand function, and pain reduction without the need for medication or surgery. ^{1 2 3 4 11}

Eligibility Criteria

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

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)

Treatment Details

Interventions

• Transcranial Direct Current Stimulation

Participant Groups

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+

Findings from Research

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) 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]

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, 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation on the autonomic modulation and exercise time in individuals with spinal cord injury. A case report. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Intensity dependent effects of transcranial direct current stimulation on corticospinal excitability in chronic spinal cord injury. [2022]

3. England pubmed.ncbi.nlm.nih.gov

White matter changes in corticospinal tract associated with improvement in arm and hand functions in incomplete cervical spinal cord injury: pilot case series. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Improved grasp function with transcranial direct current stimulation in chronic spinal cord injury. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of transcranial direct current stimulation for the management of neuropathic pain after spinal cord injury: a meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

9. England pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

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

11. Ireland pubmed.ncbi.nlm.nih.gov

Delayed pain decrease following M1 tDCS in spinal cord injury: A randomized controlled clinical trial. [2018]