Clinical trial NCT04655963: Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)
Official title: Neuromodulation and Plasticity in Cognitive Control Neurocircuitry in Chronic Stroke
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Stroke
Keywords: stroke
rTMS
cognition
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events and Side Effects as assessed by iTBS Review of Systems
timeFrame: Approximately 6 months.
measure: Assess feasibility, of an accelerated protocol of rTMS in stroke patients looking at retention and using an rTMS a credibility questionnaire pre/post treatment.
timeFrame: Approximately 6 months.
measure: Demonstrate acceptability of an accelerated protocol of rTMS in stroke patients using an acceptability of rTMS questionnaire.
timeFrame: Approximately 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: