Stroke Clinical Trial
— ENHANCEOfficial title:
ENHANCE: Enhancing Brain Plasticity for Sensorimotor Recovery in Spastic Hemiparesis
NCT number | NCT02725853 |
Other study ID # | 108186-001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | December 1, 2021 |
Verified date | December 2021 |
Source | McGill University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 1, 2021 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 80 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Canada | CRIR | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University | Manipal University, Tel Aviv University |
Canada,
ASHWORTH B. PRELIMINARY TRIAL OF CARISOPRODOL IN MULTIPLE SCLEROSIS. Practitioner. 1964 Apr;192:540-2. — View Citation
Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. — View 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. — View Citation
Nasreddine ZS, Phillips NA, Bédirian 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. Erratum in: J Am Geriatr Soc. 2019 Sep;67(9):1991. — View 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. Epub 2007 Jan 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in active control zone of the elbow | Post-test and Follow-up test; measured using motion analysis system. | 2 weeks and 1 month | |
Secondary | Change in Fugl-Meyer Assessment of arm impairment score | Post-test and Follow-up test; Score of 66 points indicates normal functioning. | 2 weeks and 1 month | |
Secondary | Change in spasticity score | Post-test and Follow-up test; 6 point ordinal scale | 2 weeks and 1 month | |
Secondary | Change in streamlined Wolf Motor Function Test score | Post-test and Follow-up test;30 point ordinal scale | 2 weeks and 1 month | |
Secondary | Change in active range of elbow extension | Post-test and Follow-up test; measured with a hand-held goniometer | 2 weeks and 1 month | |
Secondary | Change in straightness of elbow trajectory during a reach to grasp task | Post-test and Follow-up test; measured using a motion analysis system | 2 weeks and 1 month | |
Secondary | Change in speed of endpoint movement during a reach to grasp task | Post-test and Follow-up test; measured using a motion analysis system | 2 weeks and 1 month | |
Secondary | Change in smoothness of endpoint trajectory during a reach to grasp task | Post-test and Follow-up test; measured using a motion analysis system | 2 weeks and 1 month |
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