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

January 3, 2016 updated by: Kenneth N. K. Fong, The Hong Kong Polytechnic University

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Repetitive Transcranial Magnetic Stimulation (rTMS)
Low frequency rTMS at 1 Hz was applied over P5 of the contralesional hemisphere in addition to conventional rehabilitation
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Behavioral: Conventional Rehabilitation
EXPERIMENTAL: 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
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Behavioral: Conventional Rehabilitation
Behavioral: Sensory Cueing (SC)
ACTIVE_COMPARATOR: Conventional rehabilitation
Physical therapy and occupational therapy
Behavioral: Conventional Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Behavior Inattention Test (BIT)
Time Frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Catherine Bergego Scale (CBS)
Time Frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)

Secondary Outcome Measures

Outcome Measure
Time Frame
Fugl-Meyer Assessment (FMA)
Time Frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Action Research Arm Test (ARAT)
Time Frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Modified Barthel index (MBI)
Time Frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (ESTIMATE)

January 1, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 3, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20130720002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Repetitive Transcranial Magnetic Stimulation (rTMS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe