Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia

NCT ID: NCT01850836

Last Updated: 2013-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-01-31

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.

Conditions

Non Fluent Aphasia in Subacute Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Real rTMS

19 subacute stroke pts with aphasia received 10 rTMS (5sessions/week) for 2 successive weeks

Group Type: ACTIVE_COMPARATOR

repetitive transcranial magnetic stimulation

Intervention Type: PROCEDURE

Sham rTMS

10 patients received sham rTMS stimulation (5 sessions/week) for 2 successive weeks

Group Type: SHAM_COMPARATOR

repetitive transcranial magnetic stimulation

Intervention Type: PROCEDURE

Interventions

repetitive transcranial magnetic stimulation

Intervention Type: PROCEDURE

Other Intervention Names

rTMS

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Eman M. Khedr

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

rTMS in Rehab of aphasia

Identifier Type: -

Identifier Source: org_study_id