- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03164213
Facilitation of Brain Plasticity for Language Recovery in Patients With Aphasia Due to Stroke
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nachum Soroker, M.D
- Phone Number: 052-3625193
- Email: nachums@clalit.org.il
Study Contact Backup
- Name: Corinne R Zarfati, M.D.
- Phone Number: 052-8855626
- Email: CorinneS@clalit.org.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients post stroke with right hemiplegia and aphasia with cognitive capacity to understand instructions and at the aphasia cut-of level defined by "SHEMESH" assessment
Exclusion Criteria:
- unstable clinical state, craniotomy, epilepsy, heart pacer or lack of cooperation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental tDCS
TDCS stimulation at the left M1 region followed by naming therapy.
The intervention will be given daily for duration of two weeks (5 days/week).
|
The anode will be placed over the left M1 representation of the hand (C3 of the 10-20 EEG system).
Twenty minutes of anodal-tDCS (1mA) will be administered at the beginning of the daily treatment session.
Following the stimulation will be 45 minutes of naming therapy.
Other Names:
|
Sham Comparator: sham tDCS
Sham tDCS at the left M1 region followed by naming therapy.
The intervention will be given daily for duration of two weeks (5 days/week).
|
The anode will be placed over the left M1 representation of the hand (C3 of the 10-20 EEG system). Twenty minutes of sham-tDCS will be administered at the beginning of the daily treatment session. During sham-tDCS, the current will be ramped up and remained at 1mA only for 30 s before ramping down, which does not affect neural functions, but assures effective blinding of participants due to the initial tingling sensation on the scalp. Following the sham stimulation will be 45 minutes of naming therapy. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in "Shemesh" 100 nouns test (Biran and Friedmann 2005)
Time Frame: baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
|
language test
|
baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Western Aphasia Battery Hebrew
Time Frame: baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
|
aphasia assessment
|
baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
|
Change in Psycholinguistic Assessments of Language Processing in Aphasia
Time Frame: baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
|
psycholinguistical assessment of aphasia
|
baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nachum Soroker, M.D., Loewenstein Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- loe170037ctil
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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