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
About this trial
This is an interventional treatment trial for Stroke focused on measuring Unilateral neglect, Right hemiplegia
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
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
NCT ID
NCT02645344
First Posted
December 23, 2015
Last Updated
January 3, 2016
Sponsor
The Hong Kong Polytechnic University
Collaborators
West China Hospital
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
Learn more about this trial
Effects of Repetitive Transcranial Magnetic Stimulation Combined With Sensory Cueing on Unilateral Neglect in Subacute Patients With Right Hemispheric Stroke
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