- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03149224
Detection of Error Related Potentials in Stroke Patients (DERPSP)
Study Overview
Status
Conditions
Detailed Description
The experiment includes two parts, cognitive and motor parts, which will be conducted over different sessions in different days. Patients will fill in a consent form, and pre questionnaire form in the first session, and a post questionnaire at the end the last session.
EEG activity and eye movements will be recorded using BrainProducts EEG system. At the beginning of each session an EEG cap will be placed on the patient's head and conductive gel will be inserted between the cap and the head.
Session I - cognitive part: The cognitive parts involves the well-known oddball and Eriksen flanker tasks, which are expected to elicit P300 and ERN, respectively. Both tasks will be performed in one session unless the patient will be tired, in which case they will be performed in two sessions (in two different days). In the oddball task patients will be shown a sequence of simple geometrical shapes, including a standard blue circle, a large blue circle and a square. The probability of these shapes will be 80%, 10% and 10%, respectively. Each shape will appear for 100mse every 1500-2000msec. Patients will be asked to press the space-bar (with the unaffected hand) when the large blue circle appears. There will be 3 blocks of 400 shapes each. This task will last one hour with breaks between the blocks. In the Eriksen flanker task patients will be shown a sequence of congruent, non-congruent and neutral stimuli. Each stimulus will include a central pair of arrows, flanked at the top and bottom by two other pairs of either arrows or squares. In congruent and non-congruent stimuli the top and bottom pairs include arrows that are either in the same (congruent) or opposite (non-congruent) direction as the central pair, while in neutral stimuli the top and bottom pairs are squares. Each stimulus will appear for 200msec every 1500-2000msec. Patients will be asked to press the left or right arrow on the keyboard (with the unaffected hand) according to the direction of the arrows in the central pair as fast as possible. There will be 8 blocks of 64 stimuli each and will last 45-60min, including breaks.
Sessions II-V: Patients will sit in front of a computer screen and will play a simple computer game by moving a cursor using a Joystick, and reaching the target on the screen. Each block of reaching movements will be conducted with the same hand, and different blocks will be conducted with the affected or unaffected hands. During reaching movements with the unaffected hand there will be random jumps in the position of the target and/or cursor. The number of reaching movements in each block will be adjusted to the comfort of each patient, but will be limited to 50. A total of 250 reaching movements will be performed with each hand, over 60-120min depending on the number and duration of the breaks. The experiment will be conducted over 1-4 sessions depending on how long the patient will be able to participate in each day.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Boris Chalabian, Dr
- Phone Number: +972506267333
- Email: boris1962@yahoo.com
Study Contact Backup
- Name: Sigal Gottlieb
- Phone Number: +972507782393
- Email: sigalgot@campus.technion.ac.il
Study Locations
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Please Select
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Haifa, Please Select, Israel, 34816
- Recruiting
- Bnai Zion
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Contact:
- Miriam Zacksenhouse, Prof.
- Email: mermz@tx.technion.ac.il
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Haifa, Please Select, Israel, 34816
- Recruiting
- Loewenstein Hospital
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Contact:
- Devora Asher, MD
- Email: dasher@clalit.org.il
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- First stroke
- Rehabilitation time don't exceed one year
Exclusion Criteria:
- Mental disorders
- Additional neuromuscular disease
- Significant cognitive dysfunction (as defined by a score <20 on Mini Mental Status Examination).
- Visual impairments
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Voltage fluctuations resulting from brain activity after patients fail to reach the target
Time Frame: one year after the first stroke
|
Change in brain wave activity after patients fail to reach the target as compared with baseline measured in tens of micro-volts
|
one year after the first stroke
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
- 0005-16-BNZ
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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