Accelerated rTMS for Apathy After Stroke
This study is looking at whether a treatment called repetitive transcranial magnetic stimulation (rTMS) can help people who experience apathy after a stroke. Apathy means a loss of motivation and interest in activities. The study will compare active rTMS using the MagVenture MagPro TMS System to a sham (inactive) treatment. Researchers will use a Brainsight Neuronavigation System to precisely target the treatment area in the brain. They want to see if rTMS can reduce apathy symptoms, measured by scales like the Lille Apathy Rating Scale (LARS) and Apathy Evaluation Scale (AES), and if it's safe. You may be able to join if you are at least 40 years old, had a stroke at least 6 months ago, and have significant apathy. The study plans to enroll 40 participants, but its current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 40 participants to compare active rTMS to a sham treatment.
- What's involved
- You would receive rTMS treatments over six days within two weeks. Your apathy symptoms will be measured before, immediately after, and up to one month after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your apathy symptoms will be followed for one month after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Accelerated rTMS vs. Sham for Stroke Apathy
At a glance
Conditions
NCT07113067
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Medical University of South Carolina Brain Stimulation Lab
Charleston, South Carolinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Parneet Grewal, PhD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
- Lisa McTeague, PhD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
- Kevin Caulfield, PhD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
Who to contact
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Inclusion
Exclusion
What this trial measures
- Change in apathy symptoms, as measured by the Lille Apathy Rating Scale (LARS) compared to baselinePre-treatment, immediately post-treatment, and at one month post-treatment follow-up
The Lille Apathy Rating Scale (LARS) is a clinically validated 33-item structured interview assessing clinical symptoms of apathy. The structured interview is broken into 9 sub-scales including everyday productivity, interests, taking the initiative, novelty seeking, motivation, emotional responsiveness, concern, and social life. Total scores can range from -36 to +36 and are further stratified by factorial sub-scores including intellectual curiosity, emotion, action initiation, and self-awareness.
- Change in apathy symptoms as measured by the Apathy Evaluation Scale (AES) - Self and Informant VersionsPre-treatment, immediately post-treatment, and weekly for four weeks post-treatment.
The Apathy Evaluation Scale (AES) clinically validated rating scale assessing symptoms of apathy. The AES is comprised of 18 items rated on a four-point Likert-Scale assessing and quantifying emotional, behavioural and cognitive aspects of apathy. Total scores on the AES range from 18 to 72 with high scores correlating with greater severity of apathy.
- Incidence of Treatment-Emergent Adverse Events and Side Effects as assessed by change in the Review of Systems Criteria compared to baselineAfter each session of rTMS during each of six treatment days within two weeks
A review of systems questionnaire will be administered to rate the subjective symptom (headache, scalp pain, arm/hand pain, other pain(s), numbness/tingling, other sensation(s), weakness, loss of dexterity, vision/hearing change(s), ear ringing, nausea/vomiting, appetite loss, rash, skin change(s) or any other symptom(s)) on a scale of 0 to 5 (none, minimal, mild, moderate, marked, severe).
- Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery compared to baselinePre-treatment, immediately post-treatmen
Fluid cognition was measured using the iPad-administered NIH Toolbox Cognition Battery (NIHTB-CB). Fluid Cognition Composite scores were calculated by averaging the demographically adjusted (age, education, sex, race/ethnicity; Casaletto et al., 2015) T-scores for 4 NIHTB-CB tests: the flanker inhibitory control, list sorting working memory, pattern comparison processing speed, and dimensional change card sort tests. T-Scores have a mean of 50 and a standard deviation of 10. Lower scores indicate worse performance.
- Participant retention ratecalculated at the end of the study follow-up assessment period (one month post-treatment)
Percentage of participants who completed the study relative to all participants who initiated treatment. Percentage of participants who completed the study relative to all participants who initiated treatment. Percentage of participants who completed the study relative to all participants who initiated treatment.
- Patient perception of treatment acceptability as assessed by study-specific questionnaireAfter each session of rTMS during each of three treatment days within one week, and at one month post-treatment follow-up
A 15-item study-specific questionnaire of rTMS treatment acceptability, with each item rated on a scale from 1 to 5 (1 = not at all, 3 = somewhat, 5 = very much so). Higher scores indicate better acceptability for the first 10 items, lower scores indicate better acceptability for the last 5 items.
- Frontal Systems Behavior Scale (FrSBE)-Apathy scalePre-treatment, post-treatment and at 4 weeks post treatment
The Frontal Systems Behavior Scale (FrSBE) assesses behavioral changes associated with frontal lobe dysfunction, including apathy, disinhibition, and executive deficits. In this study, apathy-as measured by the FrSBE Apathy subscale-is the primary outcome.