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Enhancing Recovery of Arm Movement in Stroke Patients (ENHANCE)

Primary Purpose

Stroke, Arm, Paresis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
tDCS
sham tDCS
personalized practice
non-personalized practice
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Transcranial Direct Current Stimulation, Arm Training, Virtual Reality Exposure Therapy

Eligibility Criteria

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

Inclusion Criteria:

  1. first ever cortical or cortical/subcortical stroke confirmed by MRI/CT and medically stable;
  2. sub-acute stage of stroke (3 wk to 6 mo post-stroke);
  3. arm paresis (Chedoke-McMaster Arm Scale of 2-6 /7; Gowland et al. 1993) but able to perform voluntary elbow flexion/extension of at least 30° per direction;
  4. elbow flexor and/or extensor spasticity (> 1+/4 on Modified Ashworth Scale; Ashworth 1964; Bohannon and Smith 1987);
  5. able to provide informed consent.

Exclusion Criteria:

  1. major neurological (other than stroke) / neuromuscular / orthopaedic problems or pain that may interfere with interpretation of results;
  2. major cognitive deficits (a score <20 on the Montreal Cognitive Assessment, Nasreddine et al. 2005);
  3. history of psychiatric disorders, alcohol or drug abuse, skin sensitivity, seizures, migraines, metal in cranium and other implants (cochlear, cardiac);
  4. taking medications (e.g. epileptic and psychoactive drugs) that could affect brain activity (Poreisz 2007).

Sites / Locations

  • CRIR

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

tDCS + personalized practice

tDCS + non-personalized practice

sham tDCS + personalized practice

Arm Description

Transcranial direct current stimulation and personalized arm motor training limited to active control zones, 1 hour per day, 5 days per week for 2 weeks

Transcranial direct current stimulation and non-personalized arm motor training spanning both active control and spasticity zones, 1 hour per day, 5 days per week for 2 weeks

Sham transcranial direct current stimulation and personalized arm motor training limited to active control zones, 1 hour per day, 5 days per week for 2 weeks

Outcomes

Primary Outcome Measures

Change in active control zone of the elbow
Post-test and Follow-up test; measured using motion analysis system.

Secondary Outcome Measures

Change in Fugl-Meyer Assessment of arm impairment score
Post-test and Follow-up test; Score of 66 points indicates normal functioning.
Change in spasticity score
Post-test and Follow-up test; 6 point ordinal scale
Change in streamlined Wolf Motor Function Test score
Post-test and Follow-up test;30 point ordinal scale
Change in active range of elbow extension
Post-test and Follow-up test; measured with a hand-held goniometer
Change in straightness of elbow trajectory during a reach to grasp task
Post-test and Follow-up test; measured using a motion analysis system
Change in speed of endpoint movement during a reach to grasp task
Post-test and Follow-up test; measured using a motion analysis system
Change in smoothness of endpoint trajectory during a reach to grasp task
Post-test and Follow-up test; measured using a motion analysis system

Full Information

First Posted
January 12, 2016
Last Updated
December 29, 2021
Sponsor
McGill University
Collaborators
Tel Aviv University, Manipal University
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1. Study Identification

Unique Protocol Identification Number
NCT02725853
Brief Title
Enhancing Recovery of Arm Movement in Stroke Patients
Acronym
ENHANCE
Official Title
ENHANCE: Enhancing Brain Plasticity for Sensorimotor Recovery in Spastic Hemiparesis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
Collaborators
Tel Aviv University, Manipal University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Many people who have had a stroke have problems recovering the use of their affected arm and these problems may persist for a long time. The investigators' research will test new ways to boost recovery by using non-painful brain stimulation together with training of arm movements using basic science principles. The training program will be done using the latest technology in rehabilitation such as virtual reality and robotics. The investigators will compare three groups of patients who have had a stroke. Each group will receive different combinations of brain stimulation and arm training. Another aspect of this proposal is that the investigators will do the same training programs in three different countries - Canada, Israel and India. In this way, the investigators will combine knowledge and skills to create training programs that can be applied anywhere in the world and that are not necessarily limited to high-income countries. Also, by combining expertise, the investigators will help to build the capacity to do research in India, a middle-income country that has great potential to contribute new knowledge to rehabilitation medicine.
Detailed Description
Training approaches based on established principles of motor learning and neural plasticity and non-invasive brain stimulation such as repetitive Transcranial Magnetic Stimulation and transcranial Direct Current Stimulation (tDCS) show promise in modulating brain activity in order to enhance upper limb (UL) motor recovery. However, the potential for recovery may still not be attained if training programs do not specifically focus on remediating motor impairment as defined by motor control science. This project is driven by a major theory of motor control (Threshold Control Theory) suggesting that rather than directly specifying motor commands to muscles, descending systems regulate spatial thresholds (STs) of reflexes to generate and control voluntary movement within specific areas of joint space. In patients with stroke, ST control is diminished leading to the appearance of muscle spasticity, weakness and abnormal muscle activation patterns during voluntary movement within well-defined spatial (angular) zones. The investigators hypothesize that recovery of voluntary motor control is tightly linked to the recovery of threshold control. The investigators propose a training program that incorporates personalized tDCS to balance cortical hypo/hyperexcitability as well as personalized movement arm reaching training based on the identification of disorders in ST. Overall objectives of the proposal are: To test the effectiveness of personalized training programs to increase the range of regulation of STs in the elbow during reaching. To determine the effects of repetitive tDCS aimed at inhibiting excessive/exciting diminished cortical activity. To determine the feasibility of implementing personalized training programs in high and low-to-middle income countries. Sixty patients with sub-acute (3 wks-6 mos) stroke will be recruited in this multi-site international trial taking place in Canada, Israel and India. Participants will have spasticity in the elbow flexors and/or extensors, with some active elbow control. Each site will recruit and randomize patients into one of 3 treatment groups. Group 1 will receive tDCS and practice personalized arm motor training. Group 2 will also receive tDCS with non-specific practice. Group 3 will receive Sham-tDCS and personalized practice. Training will consist of the application of tDCS in the first 30 minutes of a 50-minute arm reaching practice session,, 5 days per week for 2 weeks. Primary outcome measures (Pre, Post, Follow-up) are elbow flexor and extensor STs and related spasticity/active control zones. Secondary measures are clinical measures of UL motor activity. By accounting for the spatial structure of motor deficits, our research will benefit both researchers and clinicians by advancing our understanding of the mechanisms underlying unimpaired/impaired motor control and recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Arm, Paresis
Keywords
Transcranial Direct Current Stimulation, Arm Training, Virtual Reality Exposure Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS + personalized practice
Arm Type
Experimental
Arm Description
Transcranial direct current stimulation and personalized arm motor training limited to active control zones, 1 hour per day, 5 days per week for 2 weeks
Arm Title
tDCS + non-personalized practice
Arm Type
Active Comparator
Arm Description
Transcranial direct current stimulation and non-personalized arm motor training spanning both active control and spasticity zones, 1 hour per day, 5 days per week for 2 weeks
Arm Title
sham tDCS + personalized practice
Arm Type
Sham Comparator
Arm Description
Sham transcranial direct current stimulation and personalized arm motor training limited to active control zones, 1 hour per day, 5 days per week for 2 weeks
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
Application of 1.5 mA tDCS for 30 minutes
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
Application of sham tDCS for 30 minutes
Intervention Type
Behavioral
Intervention Name(s)
personalized practice
Intervention Description
arm exercise consisting of whole arm movement within a restricted elbow range of motion
Intervention Type
Behavioral
Intervention Name(s)
non-personalized practice
Intervention Description
arm exercise consisting of unrestricted whole arm movement
Primary Outcome Measure Information:
Title
Change in active control zone of the elbow
Description
Post-test and Follow-up test; measured using motion analysis system.
Time Frame
2 weeks and 1 month
Secondary Outcome Measure Information:
Title
Change in Fugl-Meyer Assessment of arm impairment score
Description
Post-test and Follow-up test; Score of 66 points indicates normal functioning.
Time Frame
2 weeks and 1 month
Title
Change in spasticity score
Description
Post-test and Follow-up test; 6 point ordinal scale
Time Frame
2 weeks and 1 month
Title
Change in streamlined Wolf Motor Function Test score
Description
Post-test and Follow-up test;30 point ordinal scale
Time Frame
2 weeks and 1 month
Title
Change in active range of elbow extension
Description
Post-test and Follow-up test; measured with a hand-held goniometer
Time Frame
2 weeks and 1 month
Title
Change in straightness of elbow trajectory during a reach to grasp task
Description
Post-test and Follow-up test; measured using a motion analysis system
Time Frame
2 weeks and 1 month
Title
Change in speed of endpoint movement during a reach to grasp task
Description
Post-test and Follow-up test; measured using a motion analysis system
Time Frame
2 weeks and 1 month
Title
Change in smoothness of endpoint trajectory during a reach to grasp task
Description
Post-test and Follow-up test; measured using a motion analysis system
Time Frame
2 weeks and 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: first ever cortical or cortical/subcortical stroke confirmed by MRI/CT and medically stable; sub-acute stage of stroke (3 wk to 6 mo post-stroke); arm paresis (Chedoke-McMaster Arm Scale of 2-6 /7; Gowland et al. 1993) but able to perform voluntary elbow flexion/extension of at least 30° per direction; elbow flexor and/or extensor spasticity (> 1+/4 on Modified Ashworth Scale; Ashworth 1964; Bohannon and Smith 1987); able to provide informed consent. Exclusion Criteria: major neurological (other than stroke) / neuromuscular / orthopaedic problems or pain that may interfere with interpretation of results; major cognitive deficits (a score <20 on the Montreal Cognitive Assessment, Nasreddine et al. 2005); history of psychiatric disorders, alcohol or drug abuse, skin sensitivity, seizures, migraines, metal in cranium and other implants (cochlear, cardiac); taking medications (e.g. epileptic and psychoactive drugs) that could affect brain activity (Poreisz 2007).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mindy F Levin, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dario G Liebermann, PhD
Organizational Affiliation
Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRIR
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2H2N8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14143329
Citation
ASHWORTH B. PRELIMINARY TRIAL OF CARISOPRODOL IN MULTIPLE SCLEROSIS. Practitioner. 1964 Apr;192:540-2. No abstract available.
Results Reference
background
PubMed Identifier
3809245
Citation
Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
Results Reference
background
PubMed Identifier
8418551
Citation
Gowland C, Stratford P, Ward M, Moreland J, Torresin W, Van Hullenaar S, Sanford J, Barreca S, Vanspall B, Plews N. Measuring physical impairment and disability with the Chedoke-McMaster Stroke Assessment. Stroke. 1993 Jan;24(1):58-63. doi: 10.1161/01.str.24.1.58.
Results Reference
background
PubMed Identifier
15817019
Citation
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
Results Reference
background
PubMed Identifier
17452283
Citation
Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
Results Reference
background
PubMed Identifier
29301545
Citation
Levin MF, Banina MC, Frenkel-Toledo S, Berman S, Soroker N, Solomon JM, Liebermann DG. Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial. Trials. 2018 Jan 4;19(1):7. doi: 10.1186/s13063-017-2377-6.
Results Reference
derived

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Enhancing Recovery of Arm Movement in Stroke Patients

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