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Active, not recruitingNCT04655963NEPTUNEUpdated Oct 5, 2026

Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)

An interventional study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Chronic Stroke, sponsored by Medical University of South Carolina. Active, not recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment

Updated Oct 5, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study 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.

Read the detailed description

The goal of this pilot study is to determine whether a repetitive high-dose form of non-invasive brain stimulation is a promising and safe treatment for stroke-related cognitive difficulties. Repetitive transcranial magnetic stimulation (rTMS) is an FDA approved treatment for depression, and is used commonly to treat people for their depression. In studies of rTMS for depression and other disorders, individuals have experienced improved cognitive function. Thus, we are testing here whether cognitive function in individuals with chronic stroke could be improved by rTMS.

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Conditions studied

  • Chronic Stroke

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Keywords

  • stroke
  • rTMS
  • cognition
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Dose 1

    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.

    Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

  • DeviceRepetitive Transcranial Magnetic Stimulation (rTMS)

    MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.

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What researchers measure

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events and Side Effects as assessed by iTBS Review of Systems

    This study will be demonstrating the safety of using rTMS in stroke patients by assessing adverse events and side effects using the intermittent transcranial brain stimulation (iTBS) Review of Systems questionnaire. The minimum value of the iTBS scale is 0 and the maximum is 75, the higher the score the more severe the side effects meaning a worse outcome.

    Time frame: 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.

    This study will be demonstrating the feasibility of using rapid transcranial magnetic stimulation (rTMS) in stroke patients by assessing retention throughout the study and using a credibility scale. The credibility scale maximum is 36 and minimum is 0, a higher ratings means higher credibility score which is a better outcome.

    Time frame: Approximately 6 months.

  3. Demonstrate acceptability of an accelerated protocol of rTMS in stroke patients using an acceptability of rTMS questionnaire.

    This study will be demonstrating the acceptability of using rapid transcranial magnetic stimulation (rTMS) in stroke patients by using an rTMS acceptability scale. The acceptability scale maximum is 100 and the minimum is 0, a higher score means better outcome.

    Time frame: Approximately 6 months.

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Study locations

1 site
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
08

References and documents

Publications

  • Campbell LM, Aghamoosa S, Horn O, Fleischmann HH, Lopez J, Rbeiz KS, Madden K, Antonucci M, Revuelta G, McTeague LM, Benitez A. Feasibility of Interleaving Computerized Cognitive Training With Repetitive Transcranial Magnetic Stimulation: Pilot Studies in Mild Cognitive Impairment Due to Alzheimer's Disease and Stroke. JMIR Neurotechnol. 2026 Jul 15;5:e81437. doi: 10.2196/81437. eCollection 2026. PubMed 42459821 ↗

Study documents

  • Informed consent form · Mar 28, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Jul 30, 2026→Dec 30, 2026
Oct 5, 2026
Study completion
Jul 30, 2026→Dec 30, 2026
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Primary completion Jul 30, 2026→Dec 30, 2026
    Study completion Jul 30, 2026→Dec 30, 2026
    + 3 other changes: verification date, responsible party and documents

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT04655963
Lead sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Lisa McTeague (Associate Professor-Faculty, Medical University of South Carolina) — Principal investigator
First posted
Dec 7, 2020
Start date
Jan 14, 2021
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Oct 5, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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