Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia
Primary Purpose
Non Fluent Aphasia in Subacute Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Non Fluent Aphasia in Subacute Stroke focused on measuring Aphasia, Stroke, repetitive transcranial magnetic stimulation.
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Real rTMS
Sham rTMS
Arm Description
19 subacute stroke pts with aphasia received 10 rTMS (5sessions/week) for 2 successive weeks
10 patients received sham rTMS stimulation (5 sessions/week) for 2 successive weeks
Outcomes
Primary Outcome Measures
Hemispheric stroke scale (HSS)
Language assessment using hemispheric stroke scale (HSS)
Secondary Outcome Measures
NIH Stroke Scale (NIHSS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01850836
Brief Title
Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia
Official Title
Treatment of Aphasic Stroke Patients With rTMS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Fluent Aphasia in Subacute Stroke
Keywords
Aphasia, Stroke, repetitive transcranial magnetic stimulation.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real rTMS
Arm Type
Active Comparator
Arm Description
19 subacute stroke pts with aphasia received 10 rTMS (5sessions/week) for 2 successive weeks
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
10 patients received sham rTMS stimulation (5 sessions/week) for 2 successive weeks
Intervention Type
Procedure
Intervention Name(s)
repetitive transcranial magnetic stimulation
Other Intervention Name(s)
rTMS
Primary Outcome Measure Information:
Title
Hemispheric stroke scale (HSS)
Description
Language assessment using hemispheric stroke scale (HSS)
Time Frame
Change from Baseline in HSS at 2 months
Secondary Outcome Measure Information:
Title
NIH Stroke Scale (NIHSS)
Time Frame
Change from Baseline in NIHSS at 2 months
Other Pre-specified Outcome Measures:
Title
Stroke Aphasic Depression Questionnaire Hospital Version (SADQ-H)
Description
(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).
Time Frame
Change from Baseline in SADQ-H at 2 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Learn more about this trial
Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia
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