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Clinical Trials/NCT02645344
NCT02645344
Completed
Not Applicable

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

The Hong Kong Polytechnic University0 sites60 target enrollmentJune 2013
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
The Hong Kong Polytechnic University
Enrollment
60
Primary Endpoint
Catherine Bergego Scale (CBS)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
August 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kenneth N. K. Fong

Associate Professor

The Hong Kong Polytechnic University

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
  • Severe aphasia so as to have difficulty understanding the therapists' instructions
  • Metal implants in vivo

Outcomes

Primary Outcomes

Catherine Bergego Scale (CBS)

Time Frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)

Behavior Inattention Test (BIT)

Time Frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)

Secondary Outcomes

  • 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))

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