Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia

Non Fluent Aphasia in Subacute Stroke Clinical Trial

Official title:

Treatment of Aphasic Stroke Patients With rTMS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850836
• Other study ID #: rTMS in Rehab of aphasia
• Status: Completed
• Phase: N/A
• First received: March 12, 2013
• Last updated: May 8, 2013
• Start date: December 2010
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Broca
• Non Fluent Aphasia in Subacute Stroke
• Stroke

Intervention

Procedure:
• repetitive transcranial magnetic stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stroke Aphasic Depression Questionnaire Hospital Version (SADQ-H)	(Asking about presence of depressive symptoms within last week of stroke to be present all the days or frequent from 4-6 days, or infrequent from 1-4 days, or not at all).	Change from Baseline in SADQ-H at 2 months	No
Primary	Hemispheric stroke scale (HSS)	Language assessment using hemispheric stroke scale (HSS)	Change from Baseline in HSS at 2 months	No
Secondary	NIH Stroke Scale (NIHSS)		Change from Baseline in NIHSS at 2 months	No