Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia
Treatment of Aphasic Stroke Patients With rTMS
1 other identifier
interventional
29
0 countries
N/A
Brief Summary
To investigate the therapeutic effect of dual hemisphere repetitive transcranial magnetic stimulation (rTMS) on post-stroke non fluent aphasia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2010
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 12, 2013
CompletedFirst Posted
Study publicly available on registry
May 10, 2013
CompletedMay 10, 2013
May 1, 2013
2.1 years
March 12, 2013
May 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemispheric stroke scale (HSS)
Language assessment using hemispheric stroke scale (HSS)
Change from Baseline in HSS at 2 months
Secondary Outcomes (1)
NIH Stroke Scale (NIHSS)
Change from Baseline in NIHSS at 2 months
Other Outcomes (1)
Stroke Aphasic Depression Questionnaire Hospital Version (SADQ-H)
Change from Baseline in SADQ-H at 2 months
Study Arms (2)
Real rTMS
ACTIVE COMPARATOR19 subacute stroke pts with aphasia received 10 rTMS (5sessions/week) for 2 successive weeks
Sham rTMS
SHAM COMPARATOR10 patients received sham rTMS stimulation (5 sessions/week) for 2 successive weeks
Interventions
Eligibility Criteria
You may qualify if:
- acute hemiplegia with non-fluent aphasia, single thromboembolic non-haemorrhagic infarction documented by computerized tomography (CT) in the distribution of middle cerebral artery.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 12, 2013
First Posted
May 10, 2013
Study Start
December 1, 2010
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
May 10, 2013
Record last verified: 2013-05