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

October 15, 2020 updated by: Marko Chan, Kowloon Hospital, Hong Kong

The Treatment Effectiveness of Theta Burst Stimulation and Voluntary Trunk Rotation for Patients With Unilateral Neglect in Stroke

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kowloon, Hong Kong
        • Kowloon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TMS and trunk rotation
TMS and trunk rotation
Sham Comparator: Sham TMS and trunk rotation
Sham TMS and trunk rotation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eric Yeung, MBChB, Kowloon Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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