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Transcranial Direct Current Stimulation for Post-stroke Motor Recovery (TRANSPORT 2)

Primary Purpose

Stroke, Ischemic, Motor Activity, Upper Extremity Paralysis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sham
Low dose tDCS
High dose tDCS
mCIMT
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring stroke, stroke recovery, brain stimulation, transcranial direct current stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Each subject must meet all of the following criteria to participate in this study:

  1. 18-80 years old; and
  2. First-ever unihemispheric ischemic stroke radiologically verified and occurred within the past 30-180 days; and
  3. >10° of active wrist extension, >10° of thumb abduction/extension, and > 10° of extension in at least 2 additional digits; and
  4. Unilateral limb weakness with a Fugl-Meyer Upper Extremity score of ≤ 54 (out of 66) to avoid ceiling effects; and
  5. An absolute difference of FM-UE scores between the two baseline assessments that is ≤ 2 points indicating stable motor impairment; if subject is not stable, then he/she will be invited for a reassessment after 2 weeks (but no more than 3 reassessments); and
  6. Pre-stroke mRS ≤2; and
  7. Signed informed consent by the subject or Legally Authorized Representative (LAR).

Each Subject who meets any of the following criteria will be excluded from the study:

  1. Primary intracerebral hematoma, subarachnoid hemorrhage or bi-hemispheric or bilateral brainstem ischemic strokes;
  2. Medication use at the time of study that may interfere with tDCS, including but not limited to carbamazepine, flunarizine, sulpiride, rivastigmine, dextromethorphan;
  3. Other co-existent neuromuscular disorders (pre- or post-stroke) affecting upper extremity motor function;
  4. Other neurological disorders (pre- or post-stroke) affecting subject's ability to participate in the study;
  5. Moderate to severe cognitive impairment defined as Montreal Cognitive Assessment (MOCA) score < 20/30;
  6. History of medically uncontrolled depression or other neuro-psychiatric disorders despite medications either before or after stroke that may affect subject's ability to participate in the study;
  7. Uncontrolled hypertension despite medical treatment(s) at the time of randomization, defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and randomized later);
  8. Presence of any MRI/tDCS/TMS risk factors including but not limited to: 8a) an electrically, magnetically or mechanically activated metallic or nonmetallic implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system; 8b) a non-fixed metallic part in any part of the body, including a previous metallic injury to eye; 8c) pregnancy (effects of MRI, TMS, and tDCS on the fetus are unknown); 8d) history of seizure disorder or post-stroke seizure; 8e) preexisting scalp lesion under the intended electrode placement or a bone defect or hemicraniectomy;
  9. Planning to move from the local area within the next 6 months;
  10. Life expectancy less than 6 months;
  11. Has received Botulinum toxin injection to the affected upper extremity in the past 3 months prior to randomization or expectation that Botulinum will be given to the Upper Extremity prior to the completion of the last follow-up visit;
  12. Concurrent enrollment in another investigational stroke recovery study;
  13. Doesn't speak sufficient English to comply with study procedures;
  14. Expectation that subject cannot comply with study procedures and visits.

Sites / Locations

  • University of Alabama
  • University of California Los Angeles
  • MedStar National Rehabilitation HospitalRecruiting
  • Emory UniversityRecruiting
  • University of Kentucky
  • Baystate Medical CenterRecruiting
  • Duke University Medical CenterRecruiting
  • University of CincinnatiRecruiting
  • Cleveland VA Medical CenterRecruiting
  • Moss Rehabilitation Research InstituteRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Medical University of South CarolinaRecruiting
  • University of Texas Health Science Center / TIRR Memorial HermannRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Sham tDCS + mCIMT

2 mA tDCS + mCIMT

4 mA + mCIMT

Arm Description

Sham tDCS (Transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)

2 mA tDCS (Transcranial direct current stimulation) administers low dose or 2 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)

4 mA tDCS (Transcranial direct current stimulation) administers high dose or 4 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)

Outcomes

Primary Outcome Measures

Mean Change of Motor Impairment as Assessed by Fugl-Meyer Upper-Extremity (FM-UE) scale
The Fugl-Meyer Upper-Extremity (FM-UE) scale is a measure of motor impairment. FM-UE scale consists of a 33-item assessment which provides a global assessment of UE motor impairment. A rater observes 30 voluntary UE motions and 14 voluntary lower extremity (LE) motions, 6 tendon tap responses, and provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response). FM-UE scale is a proven scale with excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94 -0.99), and internal consistency (0.97).

Secondary Outcome Measures

Mean Change of Functional Motor Activity as assessed by Wolf Motor Function Test (WMFT)
The Wolf Motor Function Test (WMFT) is a measure of functional motor activity that quantifies upper extremity (UE) motor ability through timed and functional tasks. The WMFT consists of approximately 17 functional, strength and movement quality tasks. Each task is rated on a 6 point scale. Lower scores on the 6 point scale indicate lower functioning levels (1 = does not attempt with UE being tested, 2= UE being tested does not participate functionally, but an attempt is made to use the UE, 3= Does attempt but requires assistance of the UE not being tested, requires more than 2 attempts to complete, 4= Does attempt but may lack precision, fine coordination or fluidity, 5= Does attempt, movement similar to non-affected side but slightly slower, and 6= Does attempt and movement appears to be normal).
Mean Change of Patient Centered Quality of Life as Assessed by Stroke-Impact-Scale(SIS) hand subscale
The SIS hand subscale assesses how having a stroke impacts a patient's life. The SIS has 8 subscales which ask questions regarding a patient's physical limitations, memory and thinking, emotions and mood, ability to communicate, daily activities, mobility at home and in the community, use of hand most affected by stroke, and ability to participate in meaningful life activities. Each subscale item is rated on a scale from 5-1 (5= None of the time, 4=a little of the time, 3=Some of the time, 2=Most of the time, 1=All of the time)

Full Information

First Posted
January 30, 2019
Last Updated
September 29, 2023
Sponsor
Duke University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT03826030
Brief Title
Transcranial Direct Current Stimulation for Post-stroke Motor Recovery
Acronym
TRANSPORT 2
Official Title
TRANScranial Direct Current Stimulation for POst-stroke Motor Recovery - a Phase II sTudy (TRANSPORT 2)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Motor Activity, Upper Extremity Paralysis
Keywords
stroke, stroke recovery, brain stimulation, transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham tDCS + mCIMT
Arm Type
Sham Comparator
Arm Description
Sham tDCS (Transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
Arm Title
2 mA tDCS + mCIMT
Arm Type
Active Comparator
Arm Description
2 mA tDCS (Transcranial direct current stimulation) administers low dose or 2 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
Arm Title
4 mA + mCIMT
Arm Type
Active Comparator
Arm Description
4 mA tDCS (Transcranial direct current stimulation) administers high dose or 4 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
sham group receives no active current stimulation except 15 seconds of current ramp up in the beginning and 15 seconds of current ramp up in the end of the 30-minute session to create a scalp perception to blind the subject.
Intervention Type
Device
Intervention Name(s)
Low dose tDCS
Intervention Description
The low dose tDCS group receives direct current stimulation at 2 mA for 30 minutes per session
Intervention Type
Device
Intervention Name(s)
High dose tDCS
Intervention Description
The high dose tDCS group receives direct current stimulation at 4 mA for 30 minutes per session
Intervention Type
Behavioral
Intervention Name(s)
mCIMT
Intervention Description
All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session
Primary Outcome Measure Information:
Title
Mean Change of Motor Impairment as Assessed by Fugl-Meyer Upper-Extremity (FM-UE) scale
Description
The Fugl-Meyer Upper-Extremity (FM-UE) scale is a measure of motor impairment. FM-UE scale consists of a 33-item assessment which provides a global assessment of UE motor impairment. A rater observes 30 voluntary UE motions and 14 voluntary lower extremity (LE) motions, 6 tendon tap responses, and provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response). FM-UE scale is a proven scale with excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94 -0.99), and internal consistency (0.97).
Time Frame
Baseline through day 15 (after the intervention) and follow-up at day 45 and 105
Secondary Outcome Measure Information:
Title
Mean Change of Functional Motor Activity as assessed by Wolf Motor Function Test (WMFT)
Description
The Wolf Motor Function Test (WMFT) is a measure of functional motor activity that quantifies upper extremity (UE) motor ability through timed and functional tasks. The WMFT consists of approximately 17 functional, strength and movement quality tasks. Each task is rated on a 6 point scale. Lower scores on the 6 point scale indicate lower functioning levels (1 = does not attempt with UE being tested, 2= UE being tested does not participate functionally, but an attempt is made to use the UE, 3= Does attempt but requires assistance of the UE not being tested, requires more than 2 attempts to complete, 4= Does attempt but may lack precision, fine coordination or fluidity, 5= Does attempt, movement similar to non-affected side but slightly slower, and 6= Does attempt and movement appears to be normal).
Time Frame
Baseline through day 15 (after the intervention) and follow-up at day 45 and 105
Title
Mean Change of Patient Centered Quality of Life as Assessed by Stroke-Impact-Scale(SIS) hand subscale
Description
The SIS hand subscale assesses how having a stroke impacts a patient's life. The SIS has 8 subscales which ask questions regarding a patient's physical limitations, memory and thinking, emotions and mood, ability to communicate, daily activities, mobility at home and in the community, use of hand most affected by stroke, and ability to participate in meaningful life activities. Each subscale item is rated on a scale from 5-1 (5= None of the time, 4=a little of the time, 3=Some of the time, 2=Most of the time, 1=All of the time)
Time Frame
Baseline through day 15 (after the intervention) and follow-up at day 45 and 105

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Each subject must meet all of the following criteria to participate in this study: 18-80 years old; and First-ever unihemispheric ischemic stroke radiologically verified and occurred within the past 30-180 days; and >10° of active wrist extension, >10° of thumb abduction/extension, and > 10° of extension in at least 2 additional digits; and Unilateral limb weakness with a Fugl-Meyer Upper Extremity score of ≤ 54 (out of 66) to avoid ceiling effects; and An absolute difference of FM-UE scores between the two baseline assessments that is ≤ 2 points indicating stable motor impairment; if subject is not stable, then he/she will be invited for a reassessment after 7-14 days (but no more than 3 reassessments); and Pre-stroke mRS ≤2; and Signed informed consent by the subject or Legally Authorized Representative (LAR). Each Subject who meets any of the following criteria will be excluded from the study: Primary intracerebral hematoma, subarachnoid hemorrhage or bi-hemispheric or bilateral brainstem ischemic strokes; Medication use at the time of study that may interfere with tDCS, including but not limited to carbamazepine, flunarizine, sulpiride, rivastigmine, dextromethorphan; Other co-existent neuromuscular disorders (pre- or post-stroke) affecting upper extremity motor function; Other neurological disorders (pre- or post-stroke) affecting subject's ability to participate in the study; Moderate to severe cognitive impairment defined as Montreal Cognitive Assessment (MOCA) score < 18/30; History of medically uncontrolled depression or other neuro-psychiatric disorders despite medications either before or after stroke that may affect subject's ability to participate in the study; Uncontrolled hypertension despite medical treatment(s) at the time of randomization, defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and randomized later); Presence of any MRI/tDCS/TMS risk factors including but not limited to: 8a) an electrically, magnetically or mechanically activated metallic or nonmetallic implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system; 8b) a non-fixed metallic part in any part of the body, including a previous metallic injury to eye; 8c) pregnancy (effects of MRI, TMS, and tDCS on the fetus are unknown); 8d) history of seizure disorder or post-stroke seizure; 8e) preexisting scalp lesion under the intended electrode placement or a bone defect or hemicraniectomy; Planning to move from the local area within the next 6 months; Life expectancy less than 6 months; Has received Botulinum toxin injection to the affected upper extremity in the past 3 months prior to randomization or expectation that Botulinum will be given to the Upper Extremity prior to the completion of the last follow-up visit; Concurrent enrollment in another investigational stroke recovery study; Doesn't speak sufficient English to comply with study procedures; Expectation that subject cannot comply with study procedures and visits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wayne Feng, MD
Phone
(919) 681-1700
Email
wayne.feng@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gottfried Schlaug, MD
Email
Gottfried.Schlaug@baystatehealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Feng, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gottfried Schlaug, MD, PhD
Organizational Affiliation
Baystate Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Individual Site Status
Completed
Facility Name
MedStar National Rehabilitation Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margot Giannetti
Phone
202-877-1071
Email
margot.giannetti@medstar.net
First Name & Middle Initial & Last Name & Degree
Richard D Zorowitz, MD
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Murphy
Phone
404-712-1928
Email
smurph7@emory.edu
First Name & Middle Initial & Last Name & Degree
Michael R Borich, PhD
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Completed
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abraham Madjidov, BS
Phone
413-794-9565
Email
Abraham.Madjidov@baystatehealth.org
First Name & Middle Initial & Last Name & Degree
Gottfried Schlaug, MD
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tato Sokhadze, PhD
Phone
919-684-3801
Email
estate.sokhadze@duke.edu
First Name & Middle Initial & Last Name & Degree
Jody Feld, PhD, PT
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colin Drury
Phone
314-753-5654
Email
drurycd@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Oluwole Awosika, MD
Facility Name
Cleveland VA Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahlam Salameh
Phone
330-203-1918
Email
ais20@case.edu
First Name & Middle Initial & Last Name & Degree
Svetlana Pundik, MD
Facility Name
Moss Rehabilitation Research Institute
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sapna Kumar
Phone
215-663-6702
Email
KumarSap@einstein.edu
First Name & Middle Initial & Last Name & Degree
Dylan Edwards, PT,PhD
First Name & Middle Initial & Last Name & Degree
Ning Cao, MD
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Boos
Email
amy.boos@pitt.edu
First Name & Middle Initial & Last Name & Degree
Jason Weimer
Email
weimerjm@upmc.edu
First Name & Middle Initial & Last Name & Degree
George Wittenberg, MD
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
Valerie Salisbury
Email
eichvr@musc.edu
First Name & Middle Initial & Last Name & Degree
Chris Gregory, PhD, PT
Facility Name
University of Texas Health Science Center / TIRR Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Stevens
Phone
713-500-7914
Email
emily.a.stevens@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Gerard Francisco, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will follow the National Institute of Health Stroke Trial Network policy and procedure to share IPD. Please refer to https://nihstrokenet.org/ for detailed information.
IPD Sharing Time Frame
Please refer to https://nihstrokenet.org/ for detailed information in term of time-frame of sharing such data
IPD Sharing Access Criteria
Please refer to https://nihstrokenet.org/ for detailed information in term of time-frame of sharing such data
IPD Sharing URL
https://nihstrokenet.org/

Learn more about this trial

Transcranial Direct Current Stimulation for Post-stroke Motor Recovery

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