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Behavioural Intervention

rTMS for Stroke-Related Fatigue

N/A
Recruiting
Led By John H Kindred
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinically present fatigue
Able to walk 10m unassisted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline fss score to 3 months after last treatment
Awards & highlights

Study Summary

This trial is exploring how magnetic stimulation of the brain may reduce fatigue after a stroke. Participants receive rTMS and researchers measure fatigue, mood and cognition before and after.

Who is the study for?
This trial is for individuals aged 35-80 who have experienced a stroke at least 6 months ago and are dealing with fatigue. They must be able to walk 10 meters without help. People with metal in their head, history of seizures, multiple strokes across both brain hemispheres, other neurological or severe psychological conditions, or those who are pregnant cannot participate.Check my eligibility
What is being tested?
The study tests high frequency repetitive transcranial magnetic stimulation (rTMS) against a sham procedure to see if it reduces post-stroke fatigue. Participants will receive rTMS and their levels of fatigue, mood, and cognitive function will be assessed before and after treatment.See study design
What are the potential side effects?
Possible side effects include discomfort at the stimulation site, headache, lightheadedness, twitching of facial muscles during the procedure, or seizure (though rare). Most people tolerate rTMS well.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I often feel very tired.
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I can walk 10 meters by myself.
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I am between 35 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline mfis score to 3 months after last treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline mfis score to 3 months after last treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in Fatigue Severity Scale (FSS) score
Change in Modified Fatigue Impact Scale (MFIS) score

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Real M1 High Frequency rTMSExperimental Treatment1 Intervention
Participants will be randomly assigned to receive high-frequency repetitive transcranial magnetic stimulation (rTMS) to the top of their head for approximately 40 minutes.
Group II: Real LDLPFC High Frequency rTMSExperimental Treatment1 Intervention
Participants will be randomly assigned to receive high-frequency repetitive transcranial magnetic stimulation (rTMS) to the left frontal part of their head for approximately 40 minutes.
Group III: Sham rTMSPlacebo Group1 Intervention
Participants will be randomly assigned to receive sham/placebo repetitive transcranial magnetic stimulation (rTMS) to the their head for approximately 40 minutes. This is a control condition.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,369 Total Patients Enrolled
83 Trials studying Stroke
6,658 Patients Enrolled for Stroke
Ralph H. Johnson VA Medical CenterFED
18 Previous Clinical Trials
5,534 Total Patients Enrolled
1 Trials studying Stroke
29 Patients Enrolled for Stroke
John H KindredPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC

Media Library

High frequency repetitive transcranial magnetic stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05584124 — N/A
Stroke Research Study Groups: Real M1 High Frequency rTMS, Real LDLPFC High Frequency rTMS, Sham rTMS
Stroke Clinical Trial 2023: High frequency repetitive transcranial magnetic stimulation Highlights & Side Effects. Trial Name: NCT05584124 — N/A
High frequency repetitive transcranial magnetic stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05584124 — N/A

Frequently Asked Questions

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

What is the criteria for eligibility to join this research project?

"This medical experiment requires 60 individuals aged 35-80 who have endured a stroke at least 6 months ago. Moreover, they must be capable of unassisted 10m ambulation and exhibit signs of fatigue clinically."

Answered by AI

Is there still space available for volunteer participants in this research?

"According to the medical data hosted on clinicaltrials.gov, this trial is not currently accepting new participants as its last update was posted in October of 2022. Although it is not actively recruiting patients now, there are 1255 other studies that are including potential candidates at this moment."

Answered by AI

Are there any age restrictions for enrollment in this trial?

"This clinical research is looking for participants that are between 35 and 80 years of age."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
Ralph H. Johnson VA Medical Center, Charleston, SC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
~40 spots leftby Oct 2027