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Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia

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ClinicalTrials.gov Identifier: NCT01850836
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : May 10, 2013
Sponsor:
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
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

Responsible Party: Eman M. Khedr, Professor, Assiut University
ClinicalTrials.gov 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:
Stroke
Aphasia
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