Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT04655963

Collaborator

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

Enrollment

Location

Arm

19.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Stroke	Device: Repetitive Transcranial Magnetic Stimulation (rTMS)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Neuromodulation and Plasticity in Cognitive Control Neurocircuitry in Chronic Stroke

Actual Study Start Date :

Jan 14, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events and Side Effects as assessed by iTBS Review of Systems [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.
Assess feasibility, of an accelerated protocol of rTMS in stroke patients looking at retention and using an rTMS a credibility questionnaire pre/post treatment. [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.
Demonstrate acceptability of an accelerated protocol of rTMS in stroke patients using an acceptability of rTMS questionnaire. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lisa McTeague, PhD, Associate Professor, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT04655963

Other Study ID Numbers:

00083136
3P2CHD086844-04S1

First Posted:

Dec 7, 2020

Last Update Posted:

Mar 16, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Lisa McTeague, PhD, Associate Professor, Medical University of South Carolina

stroke

rTMS

cognition

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Mar 16, 2022