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Behavioural Intervention

Brain Stimulation for Stroke

Phase < 1
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
Age 18-90 yrs
≥6 months since first clinical stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month of follow-up.
Awards & highlights

Study Summary

This trial will test the efficacy of non-invasive brain stimulation in conjunction with upper limb training to improve bimanual motor function in stroke survivors with moderate to severe impairment.

Who is the study for?
This trial is for stroke survivors aged 18-90, at least 6 months post-stroke, with moderate to severe hand impairment but enough wrist and finger movement for tasks. Excluded are those with brainstem or cerebellar strokes, multiple sensorimotor strokes, cognitive issues, extreme hand impairment or spasticity, recent therapy or Botox treatments, and contraindications to TMS/MRI.Check my eligibility
What is being tested?
The study tests a new non-invasive brain stimulation method combined with upper limb training over 12 sessions in six weeks. Participants will undergo MRI and motor function/control tests before treatment starts, after the last session, and one month later to measure improvement.See study design
What are the potential side effects?
While not explicitly stated here, typical side effects of rTMS may include headache or discomfort at the stimulation site; however individual experiences can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must be between 18 and 90 years old.
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You had a stroke at least 6 months ago.
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Your weak hand has a score of 11 or less out of 14 on the UEFM test.
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You can move your wrist, thumb, and fingers in certain ways to do tasks, like bending your wrist and moving your fingers.
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You can move your shoulder and elbow enough to place your weak hand on a table for practicing tasks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month of follow-up.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month 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 Bimanual Assessment Measure (BAM)
Secondary outcome measures
Change Resting State Functional Magnetic Resonance Imaging(rsfMRI)
Change in ABILHAND
Change in Bimanual Grip Force Modulation Task
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: cHMC rTMS + Upper Limb Training TrainingExperimental Treatment1 Intervention
Real Repetitive Transcranial Magnetic Stimulation given to facilitate the Contralesional Higher Motor Cortices+ Upper Limb Training
Group II: Sham rTMS + Upper Limb Training TrainingPlacebo Group1 Intervention
Sham Repetitive Transcranial Magnetic Stimulation over Contralesional Higher Motor Cortices+ Upper Limb Training

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,019 Previous Clinical Trials
1,365,057 Total Patients Enrolled
14 Trials studying Stroke
1,717 Patients Enrolled for Stroke
American Heart AssociationOTHER
319 Previous Clinical Trials
4,932,404 Total Patients Enrolled
38 Trials studying Stroke
3,924,055 Patients Enrolled for Stroke
Ela Plow, PhDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
114 Total Patients Enrolled
2 Trials studying Stroke
60 Patients Enrolled for Stroke

Media Library

Novel rTMS Approach (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05381740 — Phase < 1
Stroke Research Study Groups: cHMC rTMS + Upper Limb Training Training, Sham rTMS + Upper Limb Training Training
Stroke Clinical Trial 2023: Novel rTMS Approach Highlights & Side Effects. Trial Name: NCT05381740 — Phase < 1
Novel rTMS Approach (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05381740 — Phase < 1

Frequently Asked Questions

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

What is the maximum capacity of individuals involved in this clinical experiment?

"Affirmative. Clinicaltrials.gov records attest that this medical investigation, which was originally posted on March 8th 2022, is actively recruiting 18 individuals from 1 site."

Answered by AI

Is the recruitment for this clinical trial restricted to individuals aged 75 or younger?

"To take part in this study, patients must be between 18 and 90 years old. There are 37 clinical trials for younger individuals and 1007 studies available to senior citizens."

Answered by AI

Are there any vacancies left for participants in the study?

"Affirmative. The clinical trial is seeking participants, as indicated on the website of clinicaltrials.gov; this study was first posted on March 8th 2022 and subsequently amended June 7th 2022. 18 people are required to participate across one medical centre."

Answered by AI

For whom does this clinical trial offer an opportunity to participate?

"To participate in this trial, patients must have experienced a stroke and be between the ages of 18-90. The medical study is seeking to enroll an aggregate total of 18 individuals."

Answered by AI
Recent research and studies
~6 spots leftby Mar 2025