Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)

NCT ID: NCT04655963

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-14
• Study Completion Date: 2025-12-15

Brief 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.

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.

Conditions

Chronic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: DEVICE

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

Interventions

Repetitive 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

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

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

3P2CHD086844-04S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00083136

Identifier Type: -

Identifier Source: org_study_id