NCT04658745

Brief Summary

The study aims to test the hypothesis that rTMS in the form of theta burst stimulation (TBS) over the ipsilateral and contralateral motor cortices can modulate mirror illusion-induced rhythm suppression while observing unilateral arm movement in stroke individuals. The investigators further hypothesize that this intervention will lead to the revision of interhemispheric asymmetry. Finally, this study will also explore the longitudinal relationship between rhythm suppression and motor recovery as indicated by motor excitability in the form of MEP. The results of this study will provide significant new information regarding neurophysiological motor relearning mechanisms which could inform the development and evaluation of innovative treatments for individuals with stroke

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 2, 2023

Status Verified

November 1, 2020

Enrollment Period

2.3 years

First QC Date

November 30, 2020

Last Update Submit

January 31, 2023

Conditions

StrokeHemiplegia

Keywords

Strokeupper extremityintermittent theta burst stimulationmirror visual feedbackevent-related desynchronization

Outcome Measures

Primary Outcomes (8)

  • Fugl-Meyer assessment (FMA)

    A stroke-specific, performance-based impairment index

    Baseline

  • Fugl-Meyer assessment (FMA)

    A stroke-specific, performance-based impairment index

    1 day

  • Fugl-Meyer assessment (FMA)

    A stroke-specific, performance-based impairment index

    2 weeks

  • Fugl-Meyer assessment (FMA)

    A stroke-specific, performance-based impairment index

    1-month after the completion of the intervention

  • Action Research Arm Test (ARAT)

    A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery

    Baseline (immediately before the first session)

  • Action Research Arm Test (ARAT)

    A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery

    1 day

  • Action Research Arm Test (ARAT)

    A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery

    2 weeks

  • Action Research Arm Test (ARAT)

    A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery

    1-month after the completion of the intervention

Secondary Outcomes (16)

  • EEG rhythm power

    Baseline (immediately before the first session)

  • EEG rhythm power

    1 day

  • EEG rhythm power

    2 weeks

  • EEG rhythm power

    1-month after the completion of the intervention

  • Motor-evoked Potential (MEP)

    Baseline (immediately before the first session)

  • +11 more secondary outcomes

Study Arms (3)

iTBS over the ipsilesional primary motor cortex plus mirror therapy

EXPERIMENTAL

iTBS: iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients. After the iTBS therapy, participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to synchronize with the non-affected hand (illusion on the mirror). The movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes.

Device: Intermittent theta burst stimulationBehavioral: Mirror Therapy

Sham iTBS over the ipsilesional primary motor cortex plus mirror therapy

SHAM COMPARATOR

iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere, but with a sham coil (i.e., sham iTBS). After the sham stimulation, participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to synchronize with the non-affected hand (illusion on the mirror). The movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes.

Behavioral: Mirror TherapyDevice: Sham intermittent theta burst stimulation

iTBS to the ipsilesional primary motor cortex plus sham mirror therapy

SHAM COMPARATOR

iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients. After the iTBS therapy, participants will practice the movements with the non-affected hand and try moving the affected arm at the same time, but with a covered mirror (e.g., sham mirror therapy). In the sham mirror therapy condition, the mirror is covered by a cloth and the participant is instructed to move both arms while looking at a cross mark on the covered mirror and imaging the analogous movements of the affected arm. The movement practice will involve 5 table-top tasks (same as mirror therapy) and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes.

Device: Intermittent theta burst stimulationBehavioral: Sham mirror Therapy

Interventions

Intermittent theta burst stimulationDEVICE

iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients, by using a butterfly shape coil.

iTBS over the ipsilesional primary motor cortex plus mirror therapyiTBS to the ipsilesional primary motor cortex plus sham mirror therapy
Mirror TherapyBEHAVIORAL

Participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to synchronize with the non-affected hand (illusion on the mirror). The movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes.

Sham iTBS over the ipsilesional primary motor cortex plus mirror therapyiTBS over the ipsilesional primary motor cortex plus mirror therapy
Sham intermittent theta burst stimulationDEVICE

iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients. However, a sham coil will be used, which is not associated with any stimulation effect on the brain.

Sham iTBS over the ipsilesional primary motor cortex plus mirror therapy
Sham mirror TherapyBEHAVIORAL

In sham mirror therapy, the mirror will be covered. Participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to move the non-affected hand. The participants cannot receive mirror visual feedback of the paretic upper extremity movement during the therapy. Same as mirror therapy, the movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes.

iTBS to the ipsilesional primary motor cortex plus sham mirror therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type and location of stroke - ischemic or hemorrhagic, cortical or subcortical, confirmed by medical diagnoses compatible with a unilateral lesion involvement;
  • Acute stroke patients: stroke with onset of neurological condition ≤3 months, recruited from a local hospital; Chronic stroke patients: stroke with onset of neurological condition from 6 months to 3 years, recruited from self-help organization in the community. The randomization will be pre-stratified into 2 - subacute and chronic stages, and recruit from 2 centers - acute hospital and self-help organizations in the community.
  • normal or corrected-to-normal visual acuity better than 20/60 (6/18) in the better eye;
  • right-handed, verified by the Edinburgh Handedness Inventory;
  • mild to moderately impaired hemiplegic upper extremity functions, with functional levels 5-7 as rated by the Functional Test for the Hemiplegic Upper Extremity - Hong Kong version (FTHUE-HK);
  • the ability to understand and follow simple verbal instructions;
  • the ability to participate in a therapy session lasting at least 60 minutes; and
  • consent to participate in the study.

You may not qualify if:

  • prior neurological or psychiatric disorders;
  • severe spasticity (Modified Ashworth Scale \>3) over hemiplegic upper extremity;
  • a history of recent Botox injections or acupuncture to the hemiplegic upper extremity within the past three months;
  • use of central nervous system-active medicine;
  • any contraindication to TMS, according to the guideline of the Safety of TMS Consensus group, such as the risk of epilepsy, metal implants, and pregnancy;
  • the presence of unilateral neglect as screened by the Behavioural Inattention Test (CBIT-HK); and
  • participation in another clinical study elsewhere during recruitment. Informed written consent will be obtained from all patients prior to data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kenneth FONG

Hong Kong, 000000, Hong Kong

Location

MeSH Terms

Conditions

StrokeHemiplegia

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Kenneth Nai Kuen FONG, PHD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 8, 2020

Study Start

September 23, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 2, 2023

Record last verified: 2020-11

Locations

HK(1)