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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02645344
Enrollment
60
Registered
2016-01-01
Start date
2013-06-30
Completion date
2015-08-31
Last updated
2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Unilateral neglect, Right hemiplegia

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.

Interventions

DEVICERepetitive Transcranial Magnetic Stimulation (rTMS)
BEHAVIORALSensory Cueing (SC)
BEHAVIORALConventional Rehabilitation

Sponsors

West China Hospital
CollaboratorOTHER
The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026