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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed project seeks to maximize the functional recovery achieved during the rehabilitation of the paretic upper limbs in individuals with SCI. The investigation will work towards optimizing the use of transcranial direct current stimulation (tDCS), an adjunct known to improve the effectiveness of rehabilitation. In particular, the relationship between the specificity of current delivery and functional benefit will be explored, and findings may lead to a framework that can be translated to the clinic setting.

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 data supports the effectiveness of the treatment 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, suggesting it may help with upper limb rehabilitation. ^{1 2 3 4 5}

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

Research suggests that transcranial direct current stimulation (tDCS) is generally safe for humans, with studies indicating it can be used without serious side effects. It has been tested in various conditions, including spinal cord injury, and is considered safe when applied with standard protocols. ^{1 2 3 6 7}

How does the HD-tDCS treatment for upper limb rehabilitation in spinal cord injury differ from other treatments?

HD-tDCS (high-definition transcranial direct current stimulation) is a unique treatment because it uses a noninvasive method to stimulate the brain's motor areas, potentially enhancing motor function recovery in spinal cord injury patients. Unlike traditional therapies, it specifically targets brain areas to promote adaptive changes and improve arm and hand functions. ^{1 2 3 4 5}

Research Team

Kelsey Baker, PhD

Principal Investigator

University of Texas Rio Grande Valley

Eligibility Criteria

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

iSCI occurred at least 18 months ago

My bicep strength is moderate or better.

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

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

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)

Treatment Details

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.

Participant Groups

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+

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]

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]

References

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

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

2. 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]

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. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) paired with massed practice training to promote adaptive plasticity and motor recovery in chronic incomplete tetraplegia: A pilot study. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Modeling Electric Fields in Transcutaneous Spinal Direct Current Stimulation: A Clinical Perspective. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of transcutaneous spinal direct current stimulation on corticospinal excitability in chronic incomplete spinal cord injury. [2018]