Effectiveness of Theta Burst Stimulation (TBS) and Voluntary Trunk Rotation for Neglect
Keywords
Abstract
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.
Dates
| Last Verified: | 07/31/2018 |
| First Submitted: | 08/09/2015 |
| Estimated Enrollment Submitted: | 08/16/2015 |
| First Posted: | 08/17/2015 |
| Last Update Submitted: | 08/06/2018 |
| Last Update Posted: | 08/07/2018 |
| Actual Study Start Date: | 07/31/2015 |
| Estimated Primary Completion Date: | 02/28/2019 |
| Estimated Study Completion Date: | 05/31/2019 |
Condition or disease
Intervention/treatment
Device: TMS and trunk rotation
Device: Sham TMS and trunk rotation
Phase
Arm Groups
| 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 |
Eligibility Criteria
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. Change score in Behaviorial Inattention Test (BIT) - Chinese version [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
1. Change score in Catherine Bergego Scale [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]
2. Change score in FTHUE-HK [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]
3. Change score in UE-Fugl Meyer [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]
4. Change score in FIM [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]
5. Change score in SA-SIP 30 [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]
