Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia

Not Applicable

Completed

• Conditions: Non Fluent Aphasia in Subacute Stroke
• Interventions: Procedure: repetitive transcranial magnetic stimulation

• Registration Number: NCT01850836
• Lead Sponsor: Assiut University

Brief Summary

To investigate the therapeutic effect of dual hemisphere repetitive transcranial magnetic stimulation (rTMS) on post-stroke non fluent aphasia.

Detailed Description

Thirty patients with subacute post-stroke non-fluent aphasia were randomly allocated with a ratio 2:1 to receive real (n = 20) or sham (n = 10) rTMS of the affected motor cortex. Each patient received 1000 rTMS pulses (1 Hertz at 110% of resting motor threshold) over the unaffected Broca's area and 1000 pulses (20 Hertz at 100% resting motor threshold) over affected left Broca's area for 10 consecutive days. LANGUAGE section of hemispheric stroke scale, Stroke Aphasic Depression Questionnaire Hospital Version (SADQ-H) and NIH stroke scale were assessed before, post sessions, 1 and 2 months after the last session . Motor threshold was assessed before and after the end of last session.

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-03-12
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-08
• Last Update Submitted: 2013-05-08
• Study First Posted: 2013-05-10
• Last Update Posted: 2013-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• acute hemiplegia with non-fluent aphasia, single thromboembolic non-haemorrhagic infarction documented by computerized tomography (CT) in the distribution of middle cerebral artery.

Exclusion Criteria

• head injury or neurological disease other than stroke,
• Unstable cardiac dysrhythmia,
• Fever,
• Infection,
• Hyperglycaemia
• Prior administration of tranquilizer
• Patients with no motor evoked response recorded from first dorsal interosseus (FDI) muscle of the affected hand

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real rTMS	repetitive transcranial magnetic stimulation	19 subacute stroke pts with aphasia received 10 rTMS (5sessions/week) for 2 successive weeks
Sham rTMS	repetitive transcranial magnetic stimulation	10 patients received sham rTMS stimulation (5 sessions/week) for 2 successive weeks

Primary Outcome Measures

Name	Time	Method
Hemispheric stroke scale (HSS)	Change from Baseline in HSS at 2 months	Language assessment using hemispheric stroke scale (HSS)

Secondary Outcome Measures

Name	Time	Method
NIH Stroke Scale (NIHSS)	Change from Baseline in NIHSS at 2 months