Enhancing Recovery of Arm Movement in Stroke Patients

Stroke Clinical Trial

— ENHANCE  

Official title:

ENHANCE: Enhancing Brain Plasticity for Sensorimotor Recovery in Spastic Hemiparesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725853
• Other study ID #: 108186-001
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. To test the effectiveness of personalized training programs to increase the range of regulation of STs in the elbow during reaching.

2. To determine the effects of repetitive tDCS aimed at inhibiting excessive/exciting diminished cortical activity.

3. 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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Arm
• Paresis
• Stroke

Intervention

Device:
• tDCS
Application of 1.5 mA tDCS for 30 minutes
• sham tDCS
Application of sham tDCS for 30 minutes

Behavioral:
• personalized practice
arm exercise consisting of whole arm movement within a restricted elbow range of motion
• non-personalized practice
arm exercise consisting of unrestricted whole arm movement

Locations

Country	Name	City	State
Canada	CRIR	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University	Manipal University, Tel Aviv University

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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

Outcome

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