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NCT Number: NCT04655963

Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

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

Primary outcomes

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

    Time frame: Approximately 6 months.

    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.

  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.

    Time frame: Approximately 6 months.

    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.

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

    Time frame: Approximately 6 months.

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

Neuromodulation and Plasticity in Cognitive Control Neurocircuitry in Chronic Stroke

Acronym: NEPTUNE

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 7, 2020
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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