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

NCT ID: NCT02645344

Last Updated: 2016-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-08-31

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Repetitive Transcranial Magnetic Stimulation (rTMS)

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

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

Conventional Rehabilitation

Intervention Type BEHAVIORAL

rTMS combined with 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

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

Sensory Cueing (SC)

Intervention Type BEHAVIORAL

Conventional Rehabilitation

Intervention Type BEHAVIORAL

Conventional rehabilitation

Physical therapy and occupational therapy

Group Type ACTIVE_COMPARATOR

Conventional Rehabilitation

Intervention Type BEHAVIORAL

Interventions

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Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

Sensory Cueing (SC)

Intervention Type BEHAVIORAL

Conventional Rehabilitation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Kenneth N. K. Fong

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 21187201 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23405025 (View on PubMed)

Other Identifiers

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HSEARS20130720002

Identifier Type: -

Identifier Source: org_study_id

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