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Transcranial Magnetic Stimulation
Accelerated rTMS for Post-Stroke Apathy
Phase 1
Recruiting
Led By Parneet Grewal, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
40 years old or greater
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-treatment, immediately post-treatment, and at one month post-treatment follow-up
Awards & highlights
Study Summary
This trial will study if a new brain stimulation therapy can help treat stroke-related apathy.
Who is the study for?
This trial is for individuals over 40 who've had a stroke at least 6 months ago and are experiencing apathy. They must be able to do cognitive tests, have an intact cortex in the target area confirmed by imaging, and score high on specific apathy scales. Excluded are those with other major neurological issues, severe communication problems, psychotic disorders, recent suicidality or substance abuse, pregnancy, MRI or TMS contraindications like pacemakers or metal implants.Check my eligibility
What is being tested?
The study is testing whether a high-dose version of rTMS (a non-invasive brain stimulation technique) can reduce symptoms of apathy in people who have had a stroke. The treatment targets the medial prefrontal cortex and aims to see if it's safe and effective when given at an accelerated pace.See study design
What are the potential side effects?
Potential side effects from rTMS may include discomfort at the stimulation site on the scalp, headache, lightheadedness, twitching of facial muscles during treatment sessions or seizures; however these are generally rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ calculated at the end of the study follow-up assessment period (one month post-treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~calculated at the end of the study follow-up assessment period (one month post-treatment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery compared to baseline
Change in apathy symptoms, as measured by the Lille Apathy Rating Scale (LARS) compared to baseline
Change in global cognition, as measured by the Montreal Cognitive Assessment (MoCA) compared to baseline
+3 moreSecondary outcome measures
Change in apathy symptoms, as measured by the Apathy Evaluation Scale (AES) compared to baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form
Trial Design
1Treatment groups
Experimental Treatment
Group I: Repetitive transcranial magnetic stimulationExperimental Treatment1 Intervention
All participants will receive accelerated, high-dose repetitive transcranial magnetic stimulation (rTMS) at the medial prefrontal cortex (mPFC) delivered in runs of 600 pulses, twelve times per day, for three treatment days (contiguous or non-contiguous) within a seven-day period.
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,620 Total Patients Enrolled
67 Trials studying Stroke
60,035 Patients Enrolled for Stroke
Parneet Grewal, MDPrincipal InvestigatorMedical University of South Carolina
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take part in mental health and thinking tests.You feel very uncomfortable in small spaces and can't have an MRI scan.I do not have implants or devices that could be affected by MRI or TMS.You have bleeding outside the brain.I do not have any brain disorders affecting my movement or thinking.I have a diagnosed psychotic disorder.I have visual problems that prevent me from doing tasks that require thinking.I have been diagnosed with Bipolar 1 Disorder.I am 40 years old or older.You are showing signs of not caring about things.You have shown signs of wanting to harm yourself or have attempted suicide within the past year.I am not pregnant or will confirm it with a test if I am of childbearing age.I have a preexisting condition on my scalp or skull.I had a stroke in either side of my brain over 6 months ago.I have significant difficulty speaking or understanding language.I have a history of seizures.Your brain's outer layer must be undamaged where the stimulation will be targeted, as shown by a brain scan.You are currently struggling with addiction.
Research Study Groups:
This trial has the following groups:- Group 1: Repetitive transcranial magnetic stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Repetitive transcranial magnetic stimulation for medical use?
"Due to the limited data regarding Repetitive transcranial magnetic stimulation's safety and efficacy, it was assigned a score of 1."
Answered by AI
Is this research endeavor accepting volunteers at this time?
"The information available on clinicaltrials.gov shows that this medical trial has concluded recruitment efforts; the listing was posted on June 15th 2023 before last being updated on May 18th of the same year. Nonetheless, there are 1,122 other active studies seeking candidates at present time."
Answered by AI
What results are expected from this research endeavor?
"This clinical trial is assessing the Incidence of Treatment-Emergent Adverse Events and Side Effects, as determined by iTBS Review of Systems at three time points: pre-treatment, immediately post-treatment, and weekly for four weeks following treatment. Secondary measures include modifications in global cognition (as measured via Montreal Cognitive Assessment), quality of life (assessed with the Stroke Specific Quality of Life Scale) and apathy symptoms (quantified using Apathy Evaluation Scale)."
Answered by AI
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