Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01850836
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : May 10, 2013
Information provided by (Responsible Party):
Eman M. Khedr, Assiut University

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

Condition or disease Intervention/treatment Phase
Non Fluent Aphasia in Subacute Stroke Procedure: repetitive transcranial magnetic stimulation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Aphasic Stroke Patients With rTMS
Study Start Date : December 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

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 Name: rTMS

Sham Comparator: Sham rTMS
10 patients received sham rTMS stimulation (5 sessions/week) for 2 successive weeks
Procedure: repetitive transcranial magnetic stimulation
Other Name: rTMS

Primary Outcome Measures :
  1. Hemispheric stroke scale (HSS) [ Time Frame: Change from Baseline in HSS at 2 months ]
    Language assessment using hemispheric stroke scale (HSS)

Secondary Outcome Measures :
  1. NIH Stroke Scale (NIHSS) [ Time Frame: Change from Baseline in NIHSS at 2 months ]

Other Outcome Measures:
  1. 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).

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Eman M. Khedr, Professor, Assiut University Identifier: NCT01850836     History of Changes
Other Study ID Numbers: rTMS in Rehab of aphasia
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: May 10, 2013
Last Verified: May 2013

Keywords provided by Eman M. Khedr, Assiut University:
Aphasia, Stroke, repetitive transcranial magnetic stimulation.

Additional relevant MeSH terms:
Aphasia, Broca
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms