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Effectiveness of Theta Burst Stimulation (TBS) and Voluntary Trunk Rotation for Neglect

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ClinicalTrials.gov Identifier: NCT02526238
Recruitment Status : Recruiting
First Posted : August 18, 2015
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
The Hong Kong Polytechnic University
Information provided by (Responsible Party):
Marko Chan, Kowloon Hospital, Hong Kong

Brief Summary:
This is a double blinded, randomized control trial with a pretest-posttest control and interventional group design. The assessor is blinded to all assessments and evaluations. All patients with subacute stroke undergo in-patient or out-patient rehabilitation are screened initially by a series of screening test. Suitable patients are assigned randomly to two groups respectively. Group 1 is the experimental group for Transcranial Magnetic Stimulation (TMS) and trunk rotation; Group 2 is the control group with only trunk rotation training and placebo stimulation.

Condition or disease Intervention/treatment Phase
Stroke Device: TMS and trunk rotation Device: Sham TMS and trunk rotation Not Applicable

Detailed Description:

Methodology

Sampling:

Convenient sampling will be conducted to all in and out-patients with stroke referred consecutively to occupational therapy department in Kowloon Hospital during the data collection period. Patients who meet the following inclusion criteria are admitted for study.

Inclusion criteria

  1. First or second stroke (haemorrhagic or ischaemic) confirmed by computer axial tomography scan or magnetic resonance imaging
  2. Neurological representation compatible with a unilateral right lesion involvement (i.e. left hemiplegic), exhibited left visual field inattention or neglect by following either one of below criteria:

    • obtaining a total score of star cancellation subtest in the conventional battery of the Behavioral Inattention Test <51 (out of 54)
    • obtaining a total score of line bisection subtest in the conventional battery of the Behavioral Inattention Test <7 (out of 9)
    • Score of Catherine Bergego Scale ≥ 1
  3. Right handed
  4. Less than six months since onset of stroke at study entry
  5. Able to follow simple command

Exclusion criteria

  1. Patients with severe dysphasia (either expressive or comprehensive) which restricts communication;
  2. History of other neurological disease, psychiatric disorder, or alcoholism;
  3. significant impairment in visual acuity caused by cataracts, diabetic retinopathy, glaucoma or hemianopia
  4. Any additional medical or psychological condition that would affect their ability to comply with the study protocol.

Data Collection and Treatment Procedures Written consent is obtained from all subjects before the randomization. All patients in both the experimental and placebo groups undergo the same rehabilitation process. Subject's demographic data are collected; they include age, gender, lesion site, educational level, time after onset of stroke, and global cognitive status as defined by the Mini-mental State Examination - Chinese version (CMMSE). Repeated measurements are done at day 0 (date for initial assessment), day 10 (end of treatment) and post 4 weeks. Assessments including Behavioral Inattention Test (BIT) - Chinese version, Catherine Bergego Scale, Functional Test for the hemiplegic upper extremity (FTHUE-HK), Upper-extremity portion of the Fugl-Meyer Scale (UE-FM), Functional Independence Measure (FIM), Stroke Adapted 30 item version of the Sickness Impact Profile (SA-SIP 30) score will be done at these intervals by a blind assessor.

Treatment sessions for the experimental groups and control groups are conducted by trained investigator for transcranial magnetic stimulation (TMS) and the case therapists. The conventional treatment would consist of 45 minutes of voluntary trunk rotation exercise using set-up equipment as well as 15 minutes of activities of daily living (ADL) training.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Treatment Effectiveness of Theta Burst Stimulation and Voluntary Trunk Rotation for Patients With Unilateral Neglect in Stroke
Study Start Date : August 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: TMS and trunk rotation
TMS and trunk rotation
Device: TMS and trunk rotation
TMS and trunk rotation

Sham Comparator: Sham TMS and trunk rotation
Sham TMS and trunk rotation
Device: Sham TMS and trunk rotation
Sham TMS and trunk rotation




Primary Outcome Measures :
  1. Change score in Behaviorial Inattention Test (BIT) - Chinese version [ Time Frame: Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment ]
    assessment for unilateral neglect


Secondary Outcome Measures :
  1. Change score in Catherine Bergego Scale [ Time Frame: Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment ]
    assessment for unilateral neglect

  2. Change score in FTHUE-HK [ Time Frame: Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment ]
    assessment for upper limb function

  3. Change score in UE-Fugl Meyer [ Time Frame: Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment ]
    assessment for upper limb function

  4. Change score in FIM [ Time Frame: Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks time), 4 weeks follow up after last session of treatment ]
    assessment for activities of daily living

  5. Change score in SA-SIP 30 [ Time Frame: Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment ]
    assessment for well being



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. First or second stroke (haemorrhagic or ischaemic) confirmed by computer axial tomography scan or magnetic resonance imaging
  2. Neurological representation compatible with a unilateral right lesion involvement (i.e. left hemiplegic), exhibited left visual field inattention or neglect by following either one of below criteria:

    • obtaining a total score of star cancellation subtest in the conventional battery of the Behavioural Inattention Test <51 (out of 54)
    • obtaining a total score of line bisection subtest in the conventional battery of the Behavioural Inattention Test <7 (out of 9)
    • Score of Catherine Bergego Scale ≥ 1
  3. Right handed
  4. Less than six months since onset of stroke at study entry
  5. Able to follow simple command

Exclusion Criteria:

  1. Patients with severe dysphasia (either expressive or comprehensive) which restricts communication;
  2. History of other neurological disease, psychiatric disorder, or alcoholism;
  3. significant impairment in visual acuity caused by cataracts, diabetic retinopathy, glaucoma or hemianopia
  4. Any additional medical or psychological condition that would affect their ability to comply with the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526238


Contacts
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Contact: Marko Chan, MSc. 852-24624228 ckl892@ha.org.hk
Contact: Eric Yeung, MBChB 852-31297129 yeungmp@ha.org.hk

Locations
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Hong Kong
Kowloon Hospital Recruiting
Kowloon, Hong Kong
Contact: Marko Chan, MSc.    852-24624228    ckl892@ha.org.hk   
Contact: Eric Yeung, MBChB    852-31297129    yeungmp@ha.org.hk   
Sponsors and Collaborators
Kowloon Hospital, Hong Kong
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Eric Yeung, MBChB Kowloon Hospital

Publications of Results:
Other Publications:
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Responsible Party: Marko Chan, Occupational Therapist, PhD Candidate, Kowloon Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT02526238     History of Changes
Other Study ID Numbers: KC/KE-15-0035
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Keywords provided by Marko Chan, Kowloon Hospital, Hong Kong:
transcranial magnetic stimulation
trunk rotation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases