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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 12, 2013
    Last Updated
    May 8, 2013
    Sponsor
    Assiut University
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    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

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    Dual Hemisphere rTMS for Rehabilitation of Post Stroke Aphasia

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