HD-tDCS for Upper Limb Rehabilitation in Spinal Cord Injury

Overseen By Daniel Salinas, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Rio Grande Valley

Must not be taking: Neuroactive medications

Disqualifiers: Seizures, Pregnancy, Neurological impairment, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 15

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores improving arm and hand function in people with spinal cord injuries using transcranial direct current stimulation (tDCS). It compares conventional and high-definition tDCS to determine which method is more effective when combined with regular rehab exercises. The goal is to identify the best way to deliver this therapy to aid everyday movements. It suits individuals who have had a spinal cord injury for over 18 months, with some arm and hand weakness but still able to move the biceps and triceps. As an unphased trial, this study allows participants to contribute to innovative research that could enhance rehabilitation techniques for spinal cord injuries.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial requires that you maintain your current medication regime.

What prior data suggests that this method is safe for upper limb rehabilitation in spinal cord injury?

Research has shown that both high-definition and regular transcranial direct current stimulation (tDCS) are generally safe for people. High-definition tDCS, a newer and more precise version of the treatment, is a safe and non-invasive way to stimulate the brain, with no serious side effects reported. This precision might make it safer than the traditional, broader approach of regular tDCS.

For regular tDCS, research has found that its use in human trials does not cause serious side effects, even in sessions lasting up to 40 minutes with low electrical currents. No significant brain damage or other serious problems have been linked to its use.

Overall, both high-definition and regular tDCS have demonstrated a good safety record in past studies, showing no major risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high-definition transcranial direct current stimulation (HD-tDCS) for spinal cord injury rehabilitation because it offers a more targeted approach than conventional methods. Unlike standard treatments that typically focus on physical therapy and medications to manage symptoms, HD-tDCS works by delivering electrical currents to specific areas of the brain to enhance neuroplasticity, potentially improving upper limb function. This precision in targeting brain regions could lead to better and faster recovery outcomes, making it a promising option for individuals with spinal cord injuries.

What evidence suggests that this trial's treatments could be effective for upper limb rehabilitation in spinal cord injury?

Research has shown that transcranial direct current stimulation (tDCS) can improve movement and hand grip in people with spinal cord injuries. In this trial, participants will receive either conventional tDCS or a more advanced version, high-definition tDCS (HD-tDCS), during rehabilitation. HD-tDCS targets specific brain areas more accurately than regular tDCS, potentially leading to better recovery outcomes. Studies have found that those who received tDCS during rehabilitation showed better arm and hand movement than those who did not. Early evidence suggests that HD-tDCS could enhance these benefits by focusing on the exact brain pathways affected by spinal cord injuries. Although this method is still under study, initial results are promising. ^{6 7 8 9 10}

Who Is on the Research Team?

Kelsey Baker, PhD

Principal Investigator

University of Texas Rio Grande Valley

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with cervical incomplete spinal cord injury (iSCI) between C2 and T1, at least 18 months post-injury. Participants must have certain levels of bicep and tricep strength, be able to produce specific motor responses, maintain their current medication regime, and have a weaker side of the body as indicated by UEMS scores.

Inclusion Criteria

My bicep strength is moderate or better.

My tricep strength is weak but not completely immobile, and it's weaker than my bicep.

My arm muscles respond well to nerve stimulation tests.

Exclusion Criteria

You have had a serious head injury in the past, as determined by a scale that measures the level of impairment, and your score is 5 or lower.

Pregnancy

My arm strength has improved by more than 10% recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline Control

Participants complete a baseline control phase to serve as their own control

2 weeks

2 visits (in-person)

Treatment

Participants undergo 10 sessions of either HD-tDCS or conventional tDCS paired with upper limb rehabilitation

4 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Transcranial Direct Current Stimulation
• High-definition Transcranial Direct Current Stimulation

Trial Overview The study tests how effective high-definition transcranial direct current stimulation (HD-tDCS) is compared to conventional tDCS in improving arm function during rehabilitation after an iSCI. It aims to optimize tDCS use for better recovery outcomes that could be applied clinically.

How Is the Trial Designed?

Group I: High Definition tDCS and rehabilitation Experimental Treatment 1 Intervention

10 sessions (2 hours/session) will be completed with high definition tDCS and upper limb rehabilitation. Two times prior and two times after rehabilitation, upper limb weakness and neurophysiology will be assessed.

Group II: Conventional tDCS and rehabilitation Active Control 1 Intervention

10 sessions (2 hours/session) will be completed with conventional tDCS and upper limb rehabilitation. Two times prior and two times after rehabilitation, upper limb weakness and neurophysiology will be assessed.

Who Is Running the Clinical Trial?

University of Texas Rio Grande Valley

Lead Sponsor

Trials

8

Recruited

2,700+

Published Research Related to This Trial

Transcutaneous spinal direct current stimulation (tsDCS) is predicted to be safe and can induce both transient and neuroplastic changes in the spinal cord, suggesting potential for new clinical applications, such as in spinal cord injury treatment.

The effectiveness of tsDCS is highly dependent on individual anatomy and electrode placement, highlighting the importance of using MRI-based computational models to tailor stimulation protocols for optimal clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling Electric Fields in Transcutaneous Spinal Direct Current Stimulation: A Clinical Perspective. Guidetti, M., Giannoni-Luza, S., Bocci, T., et al.[2023]

Transcutaneous spinal direct current stimulation (tsDCS) can modulate corticospinal excitability in individuals with chronic incomplete spinal cord injury, showing trends of increased excitability on one side and decreased on the other, depending on the stimulation polarity.

In a study with six participants, no significant differences were found between stimulation conditions, but the results suggest that further research is needed to optimize electrode placement and explore the potential for improved movement function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcutaneous spinal direct current stimulation on corticospinal excitability in chronic incomplete spinal cord injury. Powell, ES., Carrico, C., Salyers, E., et al.[2018]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05589415

Targeted HD-tDCS to Improve Upper Limb Rehabilitation ... The proposed project seeks to maximize the functional recovery achieved during the rehabilitation of the paretic upper limbs in individuals with SCI.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8896974/

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) ...

3. withpower.com withpower.com/trial/phase-spinal-cord-injuries-10-2020-64925

HD-tDCS for Upper Limb Rehabilitation in Spinal Cord Injury Research shows that transcranial direct current stimulation (tDCS) can improve motor function and hand grasp in people with chronic spinal cord injury, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12067987/

TELE-REHABILITATION USING TRANSCRANIAL DIRECT ... The results showed that participants who received real transcranial direct current stimulation showed better upper limb motor function, and this ...

5. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2023.1286238/full

High-definition transcranial direct current stimulation for ... This proof-of-concept study aims to develop a non-invasive brain stimulation protocol that facilitates the lesioned CST and inhibits the contralesional CRST.

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

Transcranial direct current stimulation for spinal cord injury ... Invasive and non-invasive brain stimulation techniques have been studied in clinical trials to treat chronic NP following SCI.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 mA, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666459324000088

The safety and feasibility of transcranial direct current ... Our phase I safety study indicated that a single course of tDCS was safe in patients with severe traumatic brain injury.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01112774

Application of Transcranial Direct Current Stimulation ... The purpose of this study is to determine whether the novel treatment of transcranial direct current stimulation (tDCS) could decrease the pain perception of ...

10. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2021.753464/full

Case Report: Initial Evidence of Safety and Efficacy of High ... However, the magnetic field induced in rTMS may be unsafe for patients with an implanted electrode in the head or neck area while tDCS poses no theoretical risk ...