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Completed

NCT Number: NCT02526238

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kowloon Hospital

Kowloon, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TMS and trunk rotation

Device

TMS and trunk rotation

Sham TMS and trunk rotation

Device

Sham TMS and trunk rotation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kowloon Hospital, Hong Kong

Other

Collaborators

  • The Hong Kong Polytechnic University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Aug 18, 2015
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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