Back to resultsTranscranial Direct Current Stimulation for Post-stroke Fatigue
Primary Purpose
Fatigue, Stroke Rehabilitaion
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Real Soterix Mini-CT tDCS stimulator
Sham Soterix Mini-CT tDCS stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue
Eligibility Criteria
Inclusion Criteria: Male or female patients aged >18 years Greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (CT or MRI). Fatigue severity score average >4 (severe fatigue) Willingness to remain stable on pharmacologic therapy through the duration of the study. Availability of a caregiver, family member, or friend to be present during the administration of the tDCS intervention. Exclusion Criteria: Metal in the head (except mouth) or implanted cranial or thoracic devices (i.e. pacemaker, DBS stimulator) History of seizure History of moderate to severe traumatic brain injury A score of 10 or more on the PHQ-9 or GAD-7 scale, suggestive of moderate to severe depression/anxiety. A score of less than 21 on the MoCA suggesting major neurocognitive disorder. Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied. Inability to provide informed consent Other major neurological, medical, or psychiatric illnesses that could confound results in the opinion of the site investigator.
Sites / Locations
- Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Real tDCS stimulation
Sham tDCS stimulation
Arm Description
Subjects randomized to receive real/active electrical stimulation.
Subjects randomized to receive sham/non-activating electrical stimulation.
Outcomes
Primary Outcome Measures
Mean change from baseline Fatigue Severity Scale - 7 (FSS-7)
Fatigue Severity. This seven item scale measures fatigue severity and it's effect on a person's lifestyle and activities. Items are scored on a seven point scale. Minimum score = 7, maximum score = 49 with higher score indicating greater fatigue severity.
Secondary Outcome Measures
Mean change from baseline Stroke Specific Quality Of Life scale (SS-QOL)
Quality of Life. Assesses health related quality of life, specific to individuals with stroke. Composed of 49 items, score on a 5 point guttman type scale. Scores range from 49 to 245, with higher score indicating better functioning.
Mean change from baseline Patient Health Questionnaire - 9 (PHQ-9)
Depression. A multipurpose instrument for screening, measuring, and monitoring severity of depression. Scores range from 0-27, with higher score indicating greater severity of depression.
Mean change from baseline Generalized Anxiety Disorder - 7 (GAD-7)
Anxiety. A multipurpose instrument for screening, measuring, and monitoring severity of anxiety. Scores range from 0-21, with higher score indicating greater severity of anxiety.
Mean change from baseline PROMIS-sleep disturbance
Sleep. A domain focused self report of global, physical, mental, and social health for those living with a chronic condition. Computer adapted test with higher scores indicating more sleep disturbance. Results reported as a T-score with range from 10-90 based on the United States general population average score of 50 and standard deviation of 10. Higher t-score indicates greater sleep disturbance.
Mean change from baseline Symbol Digit Modalities Test (SDMT)
Cognition. A measure of cognitive processing speed and attention. Scores range from 0-120, with higher scores better performance.
Mean change from baseline Test of Variables of Attention (T.O.V.A)
Cognition. A computerized test that measures short-term memory, with scores from 85-115 indicating a normal result. Response time, response time variability, commissions, and omissions are also recorded. A higher total number correct score indicates better performance.
Mean change from baseline Montreal cognitive assessment (MoCA)
Cognition. A brief screening tool to assess global cognitive functioning and detect mild cognitive dysfunction. Scored from 0-30 with higher score indicating better performance.
Mean Client Satisfaction Questionnaire - 8 (CSQ-8)
Feasibility. This tool is a self-report measure participant satisfaction with the intervention. Scored 8-32 with higher scores indicating greater satisfaction.
Mean change from baseline Frenchay activities index
Activities of Daily Living (ADLs). A measure of instrumental ADLs (domestic chores, leisure/work, outdoor activities) for individuals recovering from stroke. Scored from 15-60 with higher score indicating improved functioning.
Change in resting state brain functional connectivity.
Change in functional connectivity in the active vs. the sham arms assessed by a resting state functional magnetic resonance imaging scan (rs-fMRI).
Full Information
NCT ID
NCT05816603
First Posted
April 3, 2023
Last Updated
May 23, 2023
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT05816603
Brief Title
Transcranial Direct Current Stimulation for Post-stroke Fatigue
Official Title
Home-based Post-stroke Fatigue Treatment Using Transcranial Direct Current Stimulation (tDCS)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.
Detailed Description
The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a home-based non-pharmacologic intervention for post-stroke fatigue (PSF). Investigators will perform a double-blind, sham-controlled, randomized clinical trial with 24 subjects; 12 will receive sham stimulation and 12 will receive real stimulation. After a baseline assessment, the tDCS device will be applied for 20 minutes, once daily over the left dorsolateral prefrontal cortex (DLPFC), for a total of two weeks. Follow-up assessments with outcome metrics will be completed after the seventh and fourteenth sessions, and one-month following the start date (2 weeks post-treatment). In a randomly selected subset of both real and sham participants, rs-fMRI will be completed at baseline and post-treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Stroke Rehabilitaion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Real tDCS stimulation
Arm Type
Experimental
Arm Description
Subjects randomized to receive real/active electrical stimulation.
Arm Title
Sham tDCS stimulation
Arm Type
Sham Comparator
Arm Description
Subjects randomized to receive sham/non-activating electrical stimulation.
Intervention Type
Device
Intervention Name(s)
Real Soterix Mini-CT tDCS stimulator
Intervention Description
Real transcranial electrical stimulation at 2mA intensity will be delivered to the left dorsolateral prefrontal cortex, 20 minutes/day, 14-day duration.
Intervention Type
Device
Intervention Name(s)
Sham Soterix Mini-CT tDCS stimulator
Intervention Description
Sham stimulation to the left dorsolateral prefrontal cortex, 20 minutes/day, 14-day duration. The device will ramp up and ramp down current delivery from 0 mA -2 mA - 0 mA over 30 seconds at the start of the 20-minute protocol with no active stimulation until the end of the 20 minutes, at which time the 30-second ramp up/ramp down will be repeated.
Primary Outcome Measure Information:
Title
Mean change from baseline Fatigue Severity Scale - 7 (FSS-7)
Description
Fatigue Severity. This seven item scale measures fatigue severity and it's effect on a person's lifestyle and activities. Items are scored on a seven point scale. Minimum score = 7, maximum score = 49 with higher score indicating greater fatigue severity.
Time Frame
Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52))
Secondary Outcome Measure Information:
Title
Mean change from baseline Stroke Specific Quality Of Life scale (SS-QOL)
Description
Quality of Life. Assesses health related quality of life, specific to individuals with stroke. Composed of 49 items, score on a 5 point guttman type scale. Scores range from 49 to 245, with higher score indicating better functioning.
Time Frame
Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)
Title
Mean change from baseline Patient Health Questionnaire - 9 (PHQ-9)
Description
Depression. A multipurpose instrument for screening, measuring, and monitoring severity of depression. Scores range from 0-27, with higher score indicating greater severity of depression.
Time Frame
Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)
Title
Mean change from baseline Generalized Anxiety Disorder - 7 (GAD-7)
Description
Anxiety. A multipurpose instrument for screening, measuring, and monitoring severity of anxiety. Scores range from 0-21, with higher score indicating greater severity of anxiety.
Time Frame
Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)
Title
Mean change from baseline PROMIS-sleep disturbance
Description
Sleep. A domain focused self report of global, physical, mental, and social health for those living with a chronic condition. Computer adapted test with higher scores indicating more sleep disturbance. Results reported as a T-score with range from 10-90 based on the United States general population average score of 50 and standard deviation of 10. Higher t-score indicates greater sleep disturbance.
Time Frame
Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)
Title
Mean change from baseline Symbol Digit Modalities Test (SDMT)
Description
Cognition. A measure of cognitive processing speed and attention. Scores range from 0-120, with higher scores better performance.
Time Frame
Baseline (Day 1), Post-Treatment (Day 14-21)
Title
Mean change from baseline Test of Variables of Attention (T.O.V.A)
Description
Cognition. A computerized test that measures short-term memory, with scores from 85-115 indicating a normal result. Response time, response time variability, commissions, and omissions are also recorded. A higher total number correct score indicates better performance.
Time Frame
Baseline (Day 1), Post-Treatment (Day 14-21)
Title
Mean change from baseline Montreal cognitive assessment (MoCA)
Description
Cognition. A brief screening tool to assess global cognitive functioning and detect mild cognitive dysfunction. Scored from 0-30 with higher score indicating better performance.
Time Frame
Baseline (Day 1), Post-Treatment (Day 14-21)
Title
Mean Client Satisfaction Questionnaire - 8 (CSQ-8)
Description
Feasibility. This tool is a self-report measure participant satisfaction with the intervention. Scored 8-32 with higher scores indicating greater satisfaction.
Time Frame
During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)
Title
Mean change from baseline Frenchay activities index
Description
Activities of Daily Living (ADLs). A measure of instrumental ADLs (domestic chores, leisure/work, outdoor activities) for individuals recovering from stroke. Scored from 15-60 with higher score indicating improved functioning.
Time Frame
Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52)
Title
Change in resting state brain functional connectivity.
Description
Change in functional connectivity in the active vs. the sham arms assessed by a resting state functional magnetic resonance imaging scan (rs-fMRI).
Time Frame
Baseline (Day 1), Post-treatment (Day 14-21)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients aged >18 years
Greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (CT or MRI).
Fatigue severity score average >4 (severe fatigue)
Willingness to remain stable on pharmacologic therapy through the duration of the study.
Availability of a caregiver, family member, or friend to be present during the administration of the tDCS intervention.
Exclusion Criteria:
Metal in the head (except mouth) or implanted cranial or thoracic devices (i.e. pacemaker, DBS stimulator)
History of seizure
History of moderate to severe traumatic brain injury
A score of 10 or more on the PHQ-9 or GAD-7 scale, suggestive of moderate to severe depression/anxiety.
A score of less than 21 on the MoCA suggesting major neurocognitive disorder.
Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied.
Inability to provide informed consent
Other major neurological, medical, or psychiatric illnesses that could confound results in the opinion of the site investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Chaudhuri
Phone
(212) 746-1857
Email
sch4012@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Keenan
Email
alk4028@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan M Stilling, MD, MS
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Chaudhuri
Phone
212-746-1857
Email
sch4012@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Alexandra Keenan
Email
alk4028@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Joan Stilling, MD, MS
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
To achieve aims in the approved proposal. Proposals may be submitted to the study P.I. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years following publication.
Learn more about this trial
Transcranial Direct Current Stimulation for Post-stroke Fatigue
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