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HD-tDCS for Upper Limb Rehabilitation in Spinal Cord Injury

N/A
Recruiting
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
Timeline
Screening 1 day
Treatment Varies
Follow Up 2 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Congenital retrognathism
Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)
Secondary outcome measures
Electromyography
Maximum Volitional Contraction (MVC)

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

Find a Location

Who is running the clinical trial?

University of Texas Rio Grande ValleyLead Sponsor
6 Previous Clinical Trials
2,601 Total Patients Enrolled
Kelsey Baker, PhDPrincipal InvestigatorUniversity of Texas Rio Grande Valley

Media Library

High Definition tDCS and rehabilitation Clinical Trial Eligibility Overview. Trial Name: NCT05589415 — N/A
Spinal Cord Injury Research Study Groups: High Definition tDCS and rehabilitation, Conventional tDCS and rehabilitation
Spinal Cord Injury Clinical Trial 2023: High Definition tDCS and rehabilitation Highlights & Side Effects. Trial Name: NCT05589415 — N/A
High Definition tDCS and rehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05589415 — N/A
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT05589415 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this trial restricted to octogenarians or can those under 85 years of age enroll?

"Participants that are eligible to join this experiment must be in the 18-75 age bracket. In addition, there is a specific selection of 37 studies for minors and another 334 trials dedicated to persons over 65 years old."

Answered by AI

Is this study currently enrolling participants?

"Affirmative. Data provided on clinicaltrials.gov verifies that this medical trial, first posted on November 23rd 2020 is actively enrolling candidates. 24 participants are needed from one single site for the study to proceed."

Answered by AI

How can I become eligible to partake in this experiment?

"This scientific trial is seeking 24 individuals aged 18-75, with a spinal cord affliction. Eligible participants must have tricep strength of at least MRC grade 2 and be 1 muscle grade weaker than their biceps; additionally they should generate an active motor evoked potential >200 uV via transcranial magnetic stimulation. Furthermore, each subject will need to provide signed and dated informed consent as well as demonstrate that their iSCI happened no less than 18 months ago. Bicep muscles are required to register ≥3 on the Medical Research Council (MRC) scale, signify willingness to take part in all research procedures for"

Answered by AI

To what extent has enrollment been completed for this medical investigation?

"Affirmative. As evidenced on clinicaltrials.gov, this medical experiment is actively recruiting participants with the trial being posted initially on November 23rd 2020 and most recently updated October 17th 2022. The 24 needed patients will be found at a single centre of care."

Answered by AI

Who else is applying?

What state do they live in?
California
Colorado
Texas
What site did they apply to?
University of Texas Rio Grande Valley
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
2
0

What questions have other patients asked about this trial?

What are the details?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I have arthritis in L4,5,6 so neck pain and I can’t walk I can’t lift I can’t do my regular activities getting pain.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. University of Texas Rio Grande Valley: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Targeted HD-tDCS to Improve Upper Limb Rehabilitation in SCI
2020. "Targeted HD-tDCS to Improve Upper Limb Rehabilitation in SCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05589415.
All > Cervical Spondylotic Myelopathy
~0 spots leftby May 2024
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