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Behavioural Intervention

Telerehabilitation for Spinal Cord Injury

N/A
Recruiting
Led By Nuray Yozbatiran, PhD, PT
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Upper-extremity weakness associated with tetraplegia with minimal residual thumb and index finger movement sufficient to grip small objects such as marble
No brain injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 2 weeks and at 1 month
Awards & highlights

Study Summary

This trial looked at a new way to help people with spinal cord injuries regain movement in their arms.

Who is the study for?
This trial is for adults with incomplete spinal cord injury (iSCI) causing tetraplegia, who've had the condition for at least 6 months. Participants should have minimal thumb and index finger movement, no brain injuries, stable medication and therapy routines during the study, internet access at home, and no history of seizures or chronic use of certain neuroactive medications.Check my eligibility
What is being tested?
The study tests a telerehabilitation program to improve hand function in iSCI patients. It involves active transcranial direct current stimulation (tDCS), compared against sham tDCS—a placebo-like treatment—administered remotely under supervision.See study design
What are the potential side effects?
While tDCS is generally considered safe, potential side effects may include mild itching or tingling on the scalp where electrodes are placed, fatigue, headache, nausea or discomfort during or after treatment sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can grip small objects with my thumb and index finger despite having significant arm weakness.
Select...
I have not had a brain injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 2 weeks and at 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 2 weeks and at 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Secondary outcome measures
Adherence with the therapy
Feasibility of home intervention
Grip Strength
+2 more

Side effects data

From 2012 Phase 3 trial • 60 Patients • NCT01649232
10%
headache
10%
headedness / dizziness
7%
fatigue or nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active tDCS
Controls

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment1 Intervention
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Group II: Sham tDCSPlacebo Group1 Intervention
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active tDCS
2012
Completed Phase 3
~1150

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,961 Total Patients Enrolled
Mission Connect a project of TIRR FoundationUNKNOWN
Nuray Yozbatiran, PhD, PTPrincipal Investigator - The University of Texas Health Sciences Center at Houston
The University of Texas Health Science Center, Houston

Media Library

Telerehabilitation Program (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04977037 — N/A
Spinal Cord Injury Research Study Groups: Active tDCS, Sham tDCS
Spinal Cord Injury Clinical Trial 2023: Telerehabilitation Program Highlights & Side Effects. Trial Name: NCT04977037 — N/A
Telerehabilitation Program (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04977037 — N/A

Frequently Asked Questions

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

Are there any limitations on the number of participants in this medical experiment?

"Correct. Clinicaltrials.gov confirms that this clinical trial, which was first published on July 1st 2021, is still recruiting participants. 36 patients are needed to be enrolled from a single location."

Answered by AI

Is this research endeavor currently accessible to participants?

"Affirmative, clinicaltrials.gov reveals that the trial is actively recruiting patients since its posting on July 1st 2021 and last updated on October 20th 2021. The study requires 36 participants from a single medical centre to complete it."

Answered by AI

Am I eligible to get involved in this research?

"This trial is currently looking for 36 individuals aged between 18 and 70 suffering from spinal cord injuries. Furthermore, the candidate must not have suffered a brain injury; cannot alter their upper-extremity therapy or medication during the experiment; are free to use tdcs technology; and possess access to high speed internet in their home."

Answered by AI

Are any individuals over the age of 40 being accepted as part of this trial?

"This clinical trial has an allowable age range of 18 to 70 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Telerehabilitation Program for SCI
Nuray Yozbatiran 2021. "A Telerehabilitation Program for SCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04977037.
~2 spots leftby Jun 2024
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