Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)

Chronic Stroke Clinical Trial

— NEPTUNE  

Official title:

Neuromodulation and Plasticity in Cognitive Control Neurocircuitry in Chronic Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04655963
• Other study ID #: 00083136
• Secondary ID: 3P2CHD086844-04S
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 6 months.
Primary	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.	Approximately 6 months.
Primary	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.	Approximately 6 months.