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Completed

NCT Number: NCT02645344

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

Sensory Cueing (SC)

Behavioral

Conventional rehabilitation

Behavioral

Primary outcomes

  1. Behavior Inattention Test (BIT)

    Time frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)

  2. Catherine Bergego Scale (CBS)

    Time frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)

Secondary outcomes

  1. Fugl-Meyer Assessment (FMA)

    Time frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)

  2. Action Research Arm Test (ARAT)

    Time frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)

  3. Modified Barthel index (MBI)

    Time frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • West China Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 1, 2016
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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