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

Study Overview
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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.

Official Title
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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

Conditions
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Stroke

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
* Behavioral: Sensory Cueing (SC)
* Behavioral: Conventional Rehabilitation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>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)<br> <br> Behavioral: Conventional Rehabilitation<br> <br> |
| Experimental: rTMS combined with sensory cueing (SC)<br>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)<br> <br> Behavioral: Sensory Cueing (SC)<br> <br> Behavioral: Conventional Rehabilitation<br> <br> |
| Active Comparator: Conventional rehabilitation<br>Physical therapy and occupational therapy | Behavioral: Conventional Rehabilitation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unilateral neglect, Right hemiplegia