Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia

May 8, 2013 updated by: Eman M. Khedr, Assiut University

Treatment of Aphasic Stroke Patients With rTMS

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Real rTMS
19 subacute stroke pts with aphasia received 10 rTMS (5sessions/week) for 2 successive weeks
Procedure: repetitive transcranial magnetic stimulation
Other Names:
  • rTMS
Sham Comparator: Sham rTMS
10 patients received sham rTMS stimulation (5 sessions/week) for 2 successive weeks
Procedure: repetitive transcranial magnetic stimulation
Other Names:
  • rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemispheric stroke scale (HSS)
Time Frame: Change from Baseline in HSS at 2 months
Language assessment using hemispheric stroke scale (HSS)
Change from Baseline in HSS at 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
NIH Stroke Scale (NIHSS)
Time Frame: Change from Baseline in NIHSS at 2 months
Change from Baseline in NIHSS at 2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Aphasic Depression Questionnaire Hospital Version (SADQ-H)
Time Frame: Change from Baseline in SADQ-H at 2 months
(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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

May 8, 2013

First Posted (Estimate)

May 10, 2013

Study Record Updates

Last Update Posted (Estimate)

May 10, 2013

Last Update Submitted That Met QC Criteria

May 8, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rTMS in Rehab of aphasia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Fluent Aphasia in Subacute Stroke

Clinical Trials on repetitive transcranial magnetic stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe