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Brain Stimulation

Brain Stimulation 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

Must not have

History of seizure disorder

Bi-hemispheric ischemic strokes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 6 months.

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures.

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I have had strokes affecting both sides of my brain.

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I have had a stroke caused by bleeding in the brain.

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I have a scalp lesion, wound, bone defect, or have had a hemicraniectomy.

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I do not have any brain disorders affecting my movement or thinking.

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I have a diagnosed psychotic disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 6 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met