Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE) (NCT04655963) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)
United States20 participantsStarted 2021-01-14
Plain-language summary
Few treatments are available for post-stroke rehabilitation. The current study aims to develop a novel, short-term, high-dose repetitive transcranial magnetic stimulation (rTMS) based intervention to improve post-stroke cognitive problems. This study will test the safety as well as changes in cognitive function and brain activation with the administration of an accelerated rTMS protocol in chronic stroke.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have right hemisphere ischemic or hemorrhagic stroke within last 6 months chronicity
* Able to perform given cognitive tasks
* No metal implanted in the body
* A negative urine pregnancy test, if female subject of childbearing potential.
Exclusion Criteria:
* Primary intracerebral hematoma or subarachnoid hemorrhage
* Bi-hemispheric ischemic strokes
* Other concomitant neurological disorders affecting motor or cognitive function
* History of seizure disorder
* Preexisting scalp lesion or wound or bone defect or hemicraniectomy
* Substance use disorder
* Psychotic disorders
* Claustrophobia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events and Side Effects as assessed by iTBS Review of Systems
Timeframe: Approximately 6 months.
2
Assess feasibility, of an accelerated protocol of rTMS in stroke patients looking at retention and using an rTMS a credibility questionnaire pre/post treatment.
Timeframe: Approximately 6 months.
3
Demonstrate acceptability of an accelerated protocol of rTMS in stroke patients using an acceptability of rTMS questionnaire.