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HD-tDCS for Upper Limb Rehabilitation in Spinal Cord Injury

N/A

Waitlist Available

Led By Kelsey Baker, PhD

Research Sponsored by University of Texas Rio Grande Valley

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Physician diagnosed cervical incomplete spinal cord injury or lesion (iSCI)

Level of injury or lesion is between C2 and T1

Must not have

History of seizures

First-degree relative with medication-resistant epilepsy

Timeline

Screening 1 day

Treatment Varies

Follow Up 2 days

Awards & highlights

No Placebo-Only Group

Summary

This trial looks to improve upper limb recovery in people with SCI through the use of tDCS. It will explore how current delivery impacts functional benefit. Results could help in clinical settings.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated here, common side effects of tDCS may include mild itching or tingling on the scalp, fatigue, headache or nausea. Serious risks are rare but can include seizures or skin burns where electrodes are placed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a partial spinal cord injury in my neck.

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My spinal injury is between my neck and upper back.

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I am between 18 and 75 years old.

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I have been diagnosed with an incomplete spinal cord injury in my neck.

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My spinal cord injury is moderate to mild according to the AIS scale.

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My spinal injury is between my neck and upper back.

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My bicep strength is moderate or better.

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

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My arm muscles respond well to nerve stimulation tests.

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One side of my body is weaker than the other.

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My upper extremity motor skills are significantly impaired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had seizures in the past.

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A close family member has epilepsy that doesn't respond to medication.

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I have a neurological condition or impairment.

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I have pressure ulcers.

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My nerve test shows significant lower motor neuron loss at C7.

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I have stiff elbows that can't fully straighten.

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

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I am taking medication that could increase my risk of seizures.

Timeline

Screening ~ 1 day1 visit

Treatment ~ Varies

Follow Up ~ 2 days2 visits

Screening ~ 1 day

Treatment ~ Varies

Follow Up ~2 days

This trial's timeline: 1 day for screening, Varies for treatment, and 2 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Congenital retrognathism

Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)

Secondary study objectives

Electromyography

Maximum Volitional Contraction (MVC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High Definition tDCS and rehabilitationExperimental Treatment1 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 rehabilitationActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

High-definition Transcranial Direct Current Stimulation

2019

N/A

~10

0 / 19Eligibility criteria met