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Effects of Repetitive Transcranial Magnetic Stimulation Combined With Sensory Cueing on Unilateral Neglect in Subacute Patients With Right Hemispheric Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sensory Cueing (SC)
Conventional Rehabilitation
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Unilateral neglect, Right hemiplegia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of right-hemispheric stroke
  • Duration since onset of more than one week
  • Presenting with unilateral neglect, confirmed by the conventional subtests of the BIT with cutoff scores of 129
  • First-ever stroke, or unilateral neglect as the consequence of the last stroke
  • Being aged 18 or over
  • Mini Mental State Examination score of ≥17
  • Giving written consent to participate.

Exclusion Criteria:

  • Duration since onset of stroke of more than six months
  • Medically unstable
  • Epileptic seizures, unconsciousness, or intracranial hypertension
  • Serious heart disease
  • Gravid
  • Severe aphasia so as to have difficulty understanding the therapists' instructions
  • Metal implants in vivo

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Repetitive Transcranial Magnetic Stimulation (rTMS)

    rTMS combined with sensory cueing (SC)

    Conventional rehabilitation

    Arm Description

    Low frequency rTMS at 1 Hz was applied over P5 of the contralesional hemisphere in addition to conventional rehabilitation

    Vibration cueing was emitted using a wristwatch device on the hemiplegic arm combined with low frequency rTMS in addition to conventional rehabilitation

    Physical therapy and occupational therapy

    Outcomes

    Primary Outcome Measures

    Behavior Inattention Test (BIT)
    Catherine Bergego Scale (CBS)

    Secondary Outcome Measures

    Fugl-Meyer Assessment (FMA)
    Action Research Arm Test (ARAT)
    Modified Barthel index (MBI)

    Full Information

    First Posted
    December 23, 2015
    Last Updated
    January 3, 2016
    Sponsor
    The Hong Kong Polytechnic University
    Collaborators
    West China Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02645344
    Brief Title
    Effects of Repetitive Transcranial Magnetic Stimulation Combined With Sensory Cueing on Unilateral Neglect in Subacute Patients With Right Hemispheric Stroke
    Official Title
    Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) Combined With Sensory Cueing (SC) on Unilateral Neglect in Subacute Patients With Right Hemispheric Stroke: A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Hong Kong Polytechnic University
    Collaborators
    West China Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective was to compare the effects of repetitive Transcranial Magnetic Stimulation (rTMS) combined with sensory cueing (SC), rTMS alone, and conventional rehabilitation on reducing unilateral neglect (UN) and improving hemiplegic arm functions and performance of activities of daily living (ADL). Sixty subacute patients with left UN after right-hemispheric stroke were randomly assigned to three groups; rTMS combined with SC, rTMS alone, and conventional rehabilitation. rTMS at 1 Hz was applied over P5 of the contralesional hemisphere while vibration cueing was emitted using a wristwatch device on the hemiplegic arm, five days per week for two weeks. The first two groups received the same dosage of conventional rehabilitation on top of their experimental interventions. Blinded assessments were administered at baseline, 2 weeks postintervention, and four-week follow-up upon completion of training.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Unilateral neglect, Right hemiplegia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Repetitive Transcranial Magnetic Stimulation (rTMS)
    Arm Type
    Experimental
    Arm Description
    Low frequency rTMS at 1 Hz was applied over P5 of the contralesional hemisphere in addition to conventional rehabilitation
    Arm Title
    rTMS combined with sensory cueing (SC)
    Arm Type
    Experimental
    Arm Description
    Vibration cueing was emitted using a wristwatch device on the hemiplegic arm combined with low frequency rTMS in addition to conventional rehabilitation
    Arm Title
    Conventional rehabilitation
    Arm Type
    Active Comparator
    Arm Description
    Physical therapy and occupational therapy
    Intervention Type
    Device
    Intervention Name(s)
    Repetitive Transcranial Magnetic Stimulation (rTMS)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Sensory Cueing (SC)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Conventional Rehabilitation
    Primary Outcome Measure Information:
    Title
    Behavior Inattention Test (BIT)
    Time Frame
    Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
    Title
    Catherine Bergego Scale (CBS)
    Time Frame
    Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
    Secondary Outcome Measure Information:
    Title
    Fugl-Meyer Assessment (FMA)
    Time Frame
    Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
    Title
    Action Research Arm Test (ARAT)
    Time Frame
    Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
    Title
    Modified Barthel index (MBI)
    Time Frame
    Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of right-hemispheric stroke Duration since onset of more than one week Presenting with unilateral neglect, confirmed by the conventional subtests of the BIT with cutoff scores of 129 First-ever stroke, or unilateral neglect as the consequence of the last stroke Being aged 18 or over Mini Mental State Examination score of ≥17 Giving written consent to participate. Exclusion Criteria: Duration since onset of stroke of more than six months Medically unstable Epileptic seizures, unconsciousness, or intracranial hypertension Serious heart disease Gravid Severe aphasia so as to have difficulty understanding the therapists' instructions Metal implants in vivo

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21187201
    Citation
    Fong KN, Lo PC, Yu YS, Cheuk CK, Tsang TH, Po AS, Chan CC. Effects of sensory cueing on voluntary arm use for patients with chronic stroke: a preliminary study. Arch Phys Med Rehabil. 2011 Jan;92(1):15-23. doi: 10.1016/j.apmr.2010.09.014.
    Results Reference
    background
    PubMed Identifier
    23405025
    Citation
    Fong KN, Yang NY, Chan MK, Chan DY, Lau AF, Chan DY, Cheung JT, Cheung HK, Chung RC, Chan CC. Combined effects of sensory cueing and limb activation on unilateral neglect in subacute left hemiplegic stroke patients: a randomized controlled pilot study. Clin Rehabil. 2013 Jul;27(7):628-37. doi: 10.1177/0269215512471959. Epub 2013 Feb 12.
    Results Reference
    background

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    Effects of Repetitive Transcranial Magnetic Stimulation Combined With Sensory Cueing on Unilateral Neglect in Subacute Patients With Right Hemispheric Stroke

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