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

Study Overview
=================
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.

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 First or second stroke (haemorrhagic or ischaemic) confirmed by computer axial tomography scan or magnetic resonance imaging 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 Right handed Less than six months since onset of stroke at study entry Able to follow simple command Exclusion criteria Patients with severe dysphasia (either expressive or comprehensive) which restricts communication; History of other neurological disease, psychiatric disorder, or alcoholism; significant impairment in visual acuity caused by cataracts, diabetic retinopathy, glaucoma or hemianopia 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.

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

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: TMS and trunk rotation
* Device: Sham TMS and trunk rotation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First or second stroke (haemorrhagic or ischaemic) confirmed by computer axial tomography scan or magnetic resonance imaging 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 Right handed Less than six months since onset of stroke at study entry Able to follow simple command Exclusion Criteria: Patients with severe dysphasia (either expressive or comprehensive) which restricts communication; History of other neurological disease, psychiatric disorder, or alcoholism; significant impairment in visual acuity caused by cataracts, diabetic retinopathy, glaucoma or hemianopia Any additional medical or psychological condition that would affect their ability to comply with the study protocol.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMS and trunk rotation<br>TMS and trunk rotation | Device: TMS and trunk rotation<br>* TMS and trunk rotation<br>|
| Sham Comparator: Sham TMS and trunk rotation<br>Sham TMS and trunk rotation | Device: Sham TMS and trunk rotation<br>* Sham TMS and trunk rotation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change score in Behaviorial Inattention Test (BIT) - Chinese version | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transcranial magnetic stimulation, trunk rotation