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Brain Stimulation

Repetitive Transcranial Magnetic Stimulation (rTMS) for Stroke (NEPTUNE Trial)

N/A
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 months.
Awards & highlights

NEPTUNE Trial Summary

This trialwill test a novel, short-term, high-dose repetitive transcranial magnetic stimulation (rTMS) therapy to improve cognitive problems in stroke survivors. It will assess safety & brain activation.

Who is the study for?
This trial is for individuals who have had a stroke in the right hemisphere of their brain within the last 6 months and can perform certain cognitive tasks. They must not have metal implants, history of seizures, severe psychiatric disorders, claustrophobia, substance abuse issues, scalp lesions or wounds, bi-hemispheric strokes or other neurological conditions affecting cognition.Check my eligibility
What is being tested?
The study is testing an accelerated high-dose rTMS protocol to see if it's safe and whether it improves thinking skills and brain activity in people with chronic stroke. rTMS involves using magnetic fields to stimulate nerve cells in the brain.See study design
What are the potential side effects?
rTMS may cause discomfort at the stimulation site on the scalp, headache, lightheadedness or fainting. In rare cases, it could potentially trigger a seizure.

NEPTUNE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess feasibility, of an accelerated protocol of rTMS in stroke patients looking at retention and using an rTMS a credibility questionnaire pre/post treatment.
Cerebrovascular accident
Incidence of Treatment-Emergent Adverse Events and Side Effects as assessed by iTBS Review of Systems

NEPTUNE Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose 1Experimental Treatment1 Intervention
All participants would receive open-label treatment for approximately eight, 3-minute sessions of intermittent theta burst rTMS on each of three days within a seven-day span. A single session=600 pulses at 120% rMT, iTBS triplets at 50 Hz for 2 s and repeated every 10 s for a total of 190 s to left dlPFC. Total pulses=14,400.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation (rTMS)
2019
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,240 Total Patients Enrolled
67 Trials studying Stroke
60,031 Patients Enrolled for Stroke
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,721 Total Patients Enrolled
79 Trials studying Stroke
5,367 Patients Enrolled for Stroke
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,568 Total Patients Enrolled
38 Trials studying Stroke
7,780 Patients Enrolled for Stroke

Frequently Asked Questions

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

Are there any vacancies for individuals to partake in this research project?

"This investigation, which was first advertised on January 14th 2021, is presently searching for suitable participants. The details of the clinical trial were most recently updated on November 11th 2022."

Answered by AI

What is the participant size of this trial?

"Affirmative; the clinicaltrials.gov database states that this research is presently recruiting volunteers, with a debut date of January 14th 2021 and an update occurring on November 11th 2022. 40 individuals are required to be enrolled from one site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)
Lisa McTeague, PhD 2021. "Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04655963.
~3 spots leftby Dec 2024
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