Enhancing Recovery of Arm Movement in Stroke Patients

NCT02725853 | Completed

• 1 other identifier: 108186-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Arm; Paresis

Keywords

Transcranial Direct Current Stimulation; Arm Training; Virtual Reality Exposure Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Fugl-Meyer Assessment of arm impairment score

  2 weeks and 1 month

• Change in spasticity score

  2 weeks and 1 month

• Change in streamlined Wolf Motor Function Test score

  2 weeks and 1 month

• Change in active range of elbow extension

  2 weeks and 1 month

• Change in straightness of elbow trajectory during a reach to grasp task

  2 weeks and 1 month

Study Arms (3)

tDCS + personalized practice

EXPERIMENTAL

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

Device: tDCS; Behavioral: personalized practice

tDCS + non-personalized practice

ACTIVE COMPARATOR

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

Device: tDCS; Behavioral: non-personalized practice

sham tDCS + personalized practice

SHAM COMPARATOR

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

Device: sham tDCS; Behavioral: personalized practice

Interventions

tDCS DEVICE

Application of 1.5 mA tDCS for 30 minutes

tDCS + non-personalized practice; tDCS + personalized practice

sham tDCS DEVICE

Application of sham tDCS for 30 minutes

sham tDCS + personalized practice

personalized practice BEHAVIORAL

arm exercise consisting of whole arm movement within a restricted elbow range of motion

sham tDCS + personalized practice; tDCS + personalized practice

non-personalized practice BEHAVIORAL

arm exercise consisting of unrestricted whole arm movement

tDCS + non-personalized practice

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• McGill University: lead
• Tel Aviv University: collaborator
• Manipal University: collaborator

Study Sites (1)

CRIR

Montreal, Quebec, H2H2N8, Canada

Location

Related Publications (7)

• ASHWORTH B. PRELIMINARY TRIAL OF CARISOPRODOL IN MULTIPLE SCLEROSIS. Practitioner. 1964 Apr;192:540-2. No abstract available.

  PMID: 14143329 BACKGROUND

• 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.

  PMID: 3809245 BACKGROUND

• 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.

  PMID: 8418551 BACKGROUND

• 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.

  PMID: 15817019 BACKGROUND

• 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.

  PMID: 17452283 BACKGROUND

• Levin MF, Berman S, Weiss N, Parmet Y, Banina MC, Frenkel-Toledo S, Soroker N, Solomon JM, Liebermann DG. ENHANCE proof-of-concept three-arm randomized trial: effects of reaching training of the hemiparetic upper limb restricted to the spasticity-free elbow range. Sci Rep. 2023 Dec 22;13(1):22934. doi: 10.1038/s41598-023-49974-6.

  PMID: 38129527 DERIVED

• 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.

  PMID: 29301545 DERIVED

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Mindy F Levin, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

• Dario G Liebermann, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: April 1, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)