Back to resultsBrain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE) (NEPTUNE)
Primary Purpose
Chronic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Stroke focused on measuring stroke, rTMS, cognition
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
Sites / Locations
- Medical University of South CarolinaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose 1
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04655963
First Posted
November 30, 2020
Last Updated
November 11, 2022
Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT04655963
Brief Title
Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)
Acronym
NEPTUNE
Official Title
Neuromodulation and Plasticity in Cognitive Control Neurocircuitry in Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
Keywords
stroke, rTMS, cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose 1
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events and Side Effects as assessed by iTBS Review of Systems
Description
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.
Time Frame
Approximately 6 months.
Title
Assess feasibility, of an accelerated protocol of rTMS in stroke patients looking at retention and using an rTMS a credibility questionnaire pre/post treatment.
Description
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.
Time Frame
Approximately 6 months.
Title
Demonstrate acceptability of an accelerated protocol of rTMS in stroke patients using an acceptability of rTMS questionnaire.
Description
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.
Time Frame
Approximately 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Holly H Fleischmann, BS
Phone
(843) 410-9624
Email
fleischh@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa M McTeague, PhD
Phone
(843) 792-8274
Email
mcteague@musc.edu
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa M McTeague, PhD
Phone
843-792-8274
Email
mcteague@musc.edu
First Name & Middle Initial & Last Name & Degree
W
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)
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