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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS) Device
    ARM 1: Kind: Experimental
    Label: Repetitive Transcranial Magnetic Stimulation (rTMS)
    Description: Low frequency rTMS at 1 Hz was applied over P5 of the contralesional hemisphere in addition to conventional rehabilitation
    ARM 2: Kind: Experimental
    Label: rTMS combined with sensory cueing (SC)
    Description: Vibration cueing was emitted using a wristwatch device on the hemiplegic arm combined with low frequency rTMS in addition to conventional rehabilitation
  • Conventional rehabilitation Procedure
    ARM 1: Kind: Experimental
    Label: Repetitive Transcranial Magnetic Stimulation (rTMS)
    Description: Low frequency rTMS at 1 Hz was applied over P5 of the contralesional hemisphere in addition to conventional rehabilitation
    ARM 2: Kind: Experimental
    Label: rTMS combined with sensory cueing (SC)
    Description: Vibration cueing was emitted using a wristwatch device on the hemiplegic arm combined with low frequency rTMS in addition to conventional rehabilitation
    ARM 3: Kind: Experimental
    Label: Conventional rehabilitation
    Description: Physical therapy and occupational therapy
  • Sensory Cueing (SC) Behavioral
    ARM 1: Kind: Experimental
    Label: rTMS combined with sensory cueing (SC)
    Description: Vibration cueing was emitted using a wristwatch device on the hemiplegic arm combined with low frequency rTMS in addition to conventional rehabilitation

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Behavior Inattention Test (BIT) Change from baseline in 4 weeks (baseline, 2-week and 2-week after training) No
Primary Catherine Bergego Scale (CBS) Change from baseline in 4 weeks (baseline, 2-week and 2-week after training) No
Secondary Fugl-Meyer Assessment (FMA) Change from baseline in 4 weeks (baseline, 2-week and 2-week after training) No
Secondary Action Research Arm Test (ARAT) Change from baseline in 4 weeks (baseline, 2-week and 2-week after training) No
Secondary Modified Barthel index (MBI) Change from baseline in 4 weeks (baseline, 2-week and 2-week after training) No

Sponsors