Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)

Medical University of South Carolina (MUSC)

Status: Active, not recruiting

Conditions: Chronic Stroke

Treatments: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04655963

3P2CHD086844-04S1 (U.S. NIH Grant/Contract)

00083136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Dose 1

Experimental group

Description:

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:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)