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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Sensory Cueing (SC); Behavioral: Conventional Rehabilitation

• Registration Number: NCT02645344
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2015-05
• Study Completion: 2015-08
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2015-12-31
• Status Verified: 2016-01
• Study First Posted: 2016-01-01
• Last Update Submitted: 2016-01-03
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTMS combined with sensory cueing (SC)	Conventional Rehabilitation	Vibration cueing was emitted using a wristwatch device on the hemiplegic arm combined with low frequency rTMS in addition to conventional rehabilitation
Repetitive Transcranial Magnetic Stimulation (rTMS)	Repetitive Transcranial Magnetic Stimulation (rTMS)	Low frequency rTMS at 1 Hz was applied over P5 of the contralesional hemisphere in addition to conventional rehabilitation
rTMS combined with sensory cueing (SC)	Repetitive Transcranial Magnetic Stimulation (rTMS)	Vibration cueing was emitted using a wristwatch device on the hemiplegic arm combined with low frequency rTMS in addition to conventional rehabilitation
Repetitive Transcranial Magnetic Stimulation (rTMS)	Conventional Rehabilitation	Low frequency rTMS at 1 Hz was applied over P5 of the contralesional hemisphere in addition to conventional rehabilitation
rTMS combined with sensory cueing (SC)	Sensory Cueing (SC)	Vibration cueing was emitted using a wristwatch device on the hemiplegic arm combined with low frequency rTMS in addition to conventional rehabilitation
Conventional rehabilitation	Conventional Rehabilitation	Physical therapy and occupational therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)