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Behavioural Intervention

Active tDCS + task oriented practice for Spinal Cord Injury

Phase 1 & 2
Recruiting
Led By Ela Plow, PhD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 1 year post injury
Weakness of the triceps or biceps muscle in the weaker upper limb, defined as a clinically detectable difference in power compared to the power of the spared antagonist (biceps and triceps respectively) muscle, i.e., at least one muscle grade lower on the MRC scale.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up.
Awards & highlights

Study Summary

This trial is testing a new method of non-invasive brain stimulation in conjunction with upper limb training to help improve movement for people with Spinal Cord Injury.

Who is the study for?
This trial is for adults with incomplete cervical Spinal Cord Injury (C1-C8) who are at least one year post-injury and have noticeable weakness in their upper limb muscles. They should not have a pacemaker, metal in the skull, history of seizures, be pregnant, or currently receiving other upper-limb therapies.Check my eligibility
What is being tested?
The study tests a new rehabilitation method combining non-invasive brain stimulation (tDCS) with task-oriented practice to improve arm function. Participants will undergo this combined therapy for 15 sessions over up to 8 weeks and will be assessed before and after treatment, plus a follow-up after three months.See study design
What are the potential side effects?
Possible side effects from tDCS may include mild tingling, itching or discomfort at the electrode site on the scalp during stimulation. There's also a low risk of fatigue or headache following treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
It has been over a year since my injury.
Select...
I have noticeable weakness in my arm muscles compared to the other side.
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I have a spinal cord injury but can still use some muscles in my arms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Canadian Occupational Performance Measure (COPM)
Change in Capabilities of Upper Extremity Test(CUE-T)
Change in GRASSP
+4 more
Other outcome measures
Safety and Feasibility
TMS safety questionnaire

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active tDCS + task oriented practiceActive Control1 Intervention
Group II: Sham tDCS + task oriented practicePlacebo Group1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

United States Department of DefenseFED
858 Previous Clinical Trials
225,567 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
1,020 Previous Clinical Trials
1,365,624 Total Patients Enrolled
Ela Plow, PhDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
78 Total Patients Enrolled

Media Library

tDCS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03892746 — Phase 1 & 2
Spinal Cord Injury Research Study Groups: Sham tDCS + task oriented practice, Active tDCS + task oriented practice
Spinal Cord Injury Clinical Trial 2023: tDCS Highlights & Side Effects. Trial Name: NCT03892746 — Phase 1 & 2
tDCS (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03892746 — Phase 1 & 2

Frequently Asked Questions

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

How do I sign up for this opportunity to help with this research?

"49 individuals, aged 18-75 years old, who have suffered cervical spinal cord injury are being recruited for this trial. In addition to meeting the age requirement, it is essential that potential patients also: (1) have incomplete C1-C8 SCI; (2) be at least 1 year post injury; (3) demonstrate weakness of the triceps or biceps muscle in the weaker upper limb--this can be shown via a clinically detectable difference in power compared to the power of the spared antagonist(biceps and triceps respectively); and finally (4) show MRC scale results that are one grade lower than their original"

Answered by AI

How many people will be recruited for this research project?

"That is correct. According to the information on clinicaltrials.gov, this study is looking for 49 participants from 4 different locations. The trial was posted on July 12th, 2019 and was updated October 1st, 2020."

Answered by AI

Is this clinical trial available to people who are younger than 70 years old?

"Eligible patients must be between 18-75 years old to participate in this trial."

Answered by AI

Are there any current openings in this research project for participants?

"That is correct. The clinical trial, which was initially posted on July 12th 2019, appears to be actively recruiting patients according to information available on clinicaltrials.gov. In total, the study aims to enroll 49 patients at 4 different medical facilities."

Answered by AI
~5 spots leftby Sep 2024