StrokeENHANCENCT02725853
Enhancing Recovery of Arm Movement in Stroke Patients
A study testing tDCS, personalized practice and non-personalized practice in people with Stroke and Arm, run by McGill University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- What is being tested?
- tDCS, personalized practice and non-personalized practice
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ENHANCE: Enhancing Brain Plasticity for Sensorimotor Recovery in Spastic Hemiparesis
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.
Read the 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.
- Being tested
- tDCS, sham tDCS, personalized practice, non-personalized practice
- Keywords
- Transcranial Direct Current Stimulation, Arm Training, Virtual Reality Exposure Therapy
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Application of 1.5 mA tDCS for 30 minutes
sham tDCSDevice
Application of sham tDCS for 30 minutes
personalized practiceBehavioural
arm exercise consisting of whole arm movement within a restricted elbow range of motion
non-personalized practiceBehavioural
arm exercise consisting of unrestricted whole arm movement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: sham tDCS; Behavioral: personalized practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in active control zone of the elbow
Post-test and Follow-up test; measured using motion analysis system.
Measured: 2 weeks and 1 month
Secondary outcomes (7)
Change in Fugl-Meyer Assessment of arm impairment score
Post-test and Follow-up test; Score of 66 points indicates normal functioning.
Measured: 2 weeks and 1 month
Change in spasticity score
Post-test and Follow-up test; 6 point ordinal scale
Measured: 2 weeks and 1 month
Change in streamlined Wolf Motor Function Test score
Post-test and Follow-up test;30 point ordinal scale
Measured: 2 weeks and 1 month
Change in active range of elbow extension
Post-test and Follow-up test; measured with a hand-held goniometer
Measured: 2 weeks and 1 month
Change in straightness of elbow trajectory during a reach to grasp task
Post-test and Follow-up test; measured using a motion analysis system
Measured: 2 weeks and 1 month
Change in speed of endpoint movement during a reach to grasp task
Post-test and Follow-up test; measured using a motion analysis system
Measured: 2 weeks and 1 month
Change in smoothness of endpoint trajectory during a reach to grasp task
Post-test and Follow-up test; measured using a motion analysis system
Measured: 2 weeks and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University, Manipal University
- Responsible party
- Principal investigator, Mindy F. Levin, McGill University
- Investigators
- Mindy F Levin, PhD, Principal investigator, McGill UniversityDario G Liebermann, PhD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725853
- Sponsor's protocol ID
- 108186-001
- Acronym
- ENHANCE
- Status last verified
- Dec 2021
- First submitted
- 12 Jan 2016
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
ASHWORTH B. PRELIMINARY TRIAL OF CARISOPRODOL IN MULTIPLE SCLEROSIS. Practitioner. 1964 Apr;192:540-2. No abstract available.
PubMed 14143329Bohannon 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.
PubMed 3809245Gowland 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.
PubMed 8418551Nasreddine 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.
PubMed 15817019Poreisz 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.
PubMed 17452283Levin 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.
PubMed 38129527Levin 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.
PubMed 29301545
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENHANCE: Enhancing Brain Plasticity for Sensorimotor Recovery in Spastic Hemiparesis
- ClinicalTrials.gov ID
- NCT02725853
- Acronym / sponsor ID
- ENHANCE / 108186-001
- Keywords
- Transcranial Direct Current Stimulation, Arm Training, Virtual Reality Exposure Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Tel Aviv University, Manipal University
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS + personalized practice | Experimental | Device: tDCS, Behavioral: personalized practiceTranscranial direct current stimulation and personalized arm motor training limited to active control zones, 1 hour per day, 5 days per week for 2 weeks |
| tDCS + non-personalized practice | Active comparator | Device: tDCS, Behavioral: non-personalized practiceTranscranial 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 tDCS + personalized practice | Sham comparator | Device: sham tDCS, Behavioral: personalized practiceSham 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 |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSApplication of 1.5 mA tDCS for 30 minutes | Device | tDCS + non-personalized practice, tDCS + personalized practice |
| sham tDCSApplication of sham tDCS for 30 minutes | Device | sham tDCS + personalized practice |
| personalized practicearm exercise consisting of whole arm movement within a restricted elbow range of motion | Behavioural | sham tDCS + personalized practice, tDCS + personalized practice |
| non-personalized practicearm exercise consisting of unrestricted whole arm movement | Behavioural | tDCS + non-personalized practice |
Primary outcome
Change in active control zone of the elbow
Time frame: 2 weeks and 1 month
Post-test and Follow-up test; measured using motion analysis system.
7 secondary outcomes
Change in Fugl-Meyer Assessment of arm impairment score
Time frame: 2 weeks and 1 month
Change in spasticity score
Time frame: 2 weeks and 1 month
Change in streamlined Wolf Motor Function Test score
Time frame: 2 weeks and 1 month
Change in active range of elbow extension
Time frame: 2 weeks and 1 month
Change in straightness of elbow trajectory during a reach to grasp task
Time frame: 2 weeks and 1 month
Change in speed of endpoint movement during a reach to grasp task
Time frame: 2 weeks and 1 month
Change in smoothness of endpoint trajectory during a reach to grasp task
Time frame: 2 weeks and 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Background: PubMed 14143329ASHWORTH B. PRELIMINARY TRIAL OF CARISOPRODOL IN MULTIPLE SCLEROSIS. Practitioner. 1964 Apr;192:540-2. No abstract available.
- Background: PubMed 3809245Bohannon 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.
- Background: PubMed 8418551Gowland 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.
- Background: PubMed 15817019Nasreddine 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.
- Background: PubMed 17452283Poreisz 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.
- Derived from this study: PubMed 38129527Levin 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.
- Derived from this study: PubMed 29301545Levin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mindy F Levin, PhD principal investigator
McGill University
Dario G Liebermann, PhD principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS, personalized practice and non-personalized practice in people with Stroke and Arm, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in active control zone of the elbow (time frame: 2 weeks and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02725853, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.