Effects of Repetitive Transcranial Magnetic Stimulation Combined With Sensory Cueing on Unilateral Neglect in Subacute Patients With Right Hemispheric Stroke
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jun 2013
Typical duration for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 23, 2015
CompletedFirst Posted
Study publicly available on registry
January 1, 2016
CompletedJanuary 5, 2016
January 1, 2016
1.9 years
December 23, 2015
January 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Behavior Inattention Test (BIT)
Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Catherine Bergego Scale (CBS)
Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Secondary Outcomes (3)
Fugl-Meyer Assessment (FMA)
Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Action Research Arm Test (ARAT)
Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Modified Barthel index (MBI)
Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Study Arms (3)
Repetitive Transcranial Magnetic Stimulation (rTMS)
EXPERIMENTALLow frequency rTMS at 1 Hz was applied over P5 of the contralesional hemisphere in addition to conventional rehabilitation
rTMS combined with sensory cueing (SC)
EXPERIMENTALVibration cueing was emitted using a wristwatch device on the hemiplegic arm combined with low frequency rTMS in addition to conventional rehabilitation
Conventional rehabilitation
ACTIVE COMPARATORPhysical therapy and occupational therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Hong Kong Polytechnic Universitylead
- West China Hospitalcollaborator
Related Publications (2)
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.
PMID: 21187201BACKGROUNDFong 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.
PMID: 23405025BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 23, 2015
First Posted
January 1, 2016
Study Start
June 1, 2013
Primary Completion
May 1, 2015
Study Completion
August 1, 2015
Last Updated
January 5, 2016
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share