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

Stroke Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645344
• Other study ID #: HSEARS20130720002
• Status: Completed
• Phase: N/A
• First received: December 23, 2015
• Last updated: January 3, 2016
• Start date: June 2013
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: University Grants Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation (rTMS)

Behavioral:
• Sensory Cueing (SC)

• Conventional Rehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	West China Hospital

References & Publications (2)

Fong KN, Lo PC, Yu YS, Cheuk CK, Tsang TH, Po AS, Chan CC. Effects of sensory cueing on voluntary arm use for patients with chronic stroke: a preliminary study. Arch Phys Med Rehabil. 2011 Jan;92(1):15-23. doi: 10.1016/j.apmr.2010.09.014. — View Citation

Fong KN, Yang NY, Chan MK, Chan DY, Lau AF, Chan DY, Cheung JT, Cheung HK, Chung RC, Chan CC. Combined effects of sensory cueing and limb activation on unilateral neglect in subacute left hemiplegic stroke patients: a randomized controlled pilot study. Clin Rehabil. 2013 Jul;27(7):628-37. doi: 10.1177/0269215512471959. Epub 2013 Feb 12. — View Citation

Outcome

Type	Measure	Description	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