Clinical trial NCT02494908: Evidence of Neuroplasticity After Performing a Cognitive Task in Idiopathic Parkinson's Disease Patients
Official title: Can Diffusion Tensor MRI Brain Scan Demonstrate Microstructural Changes as Evidence of Neuroplasticity Following a Learning Process in Patients With Idiopathic Parkinson's Disease ?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
MRI
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Bar-Ilan University, Israel
name: Tel Aviv University
name: Sheba Medical Center
First posted: 2015-07-10
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: As seen in previous studies Diffusion Tensor Imaging (DTI) MRI is able to detect very subtle changes in brain tissue even after a very short timescale of hours resulting from performing a cognitive task and learning, We wish to explore and compare those changes to patients with idiopathic PD (IPD) and see if there are changes in the learning process and can we detect them using widely available noninvasive techniques such as MRI.

Detailed description: Aim: to utilize high sensitivity DTI MRI methodology to explore evidence for subtle microstructural brain alterations after performing a cognitive task and to compare those changes in patients with PD to healthy controls of the same age.

PD patients and controls will undergo a full cranial MRI scan for depiction of anatomy and structural abnormalities (scan duration \~40 min). Immediately afterwards the subjects will play a car race computer game (Need for Speed) for 90 minutes. Following the game, the patients will undergo an additional DTI MRI scan (\~15 minutes).

Eligibility criteria: Inclusion Criteria:

* Patients with IPD based on a clinical diagnosis of PD according to the United Kingdom Parkinson's Disease Society Brain Bank criteria (however patients with a positive family history and symmetrical onset may be included)
* Healthy subjects should have no known neurological disease matched for age and sex with the study group

Exclusion Criteria:

* History of cranial surgery, radiation therapy, tumor, stroke or significant head trauma
* History of psychiatric disease (major depression, bipolar affective disorder, schizophrenia)
* Patients with severe tremor or dyskinesias that may interfere with performance of the MRI scan
* Patients with Montreal Cognitive Assessment (MoCA) score of 22 or under
* Contraindications for MRI (metal objects: implants/shrapnel/bullet; any electrically, magnetically or mechanically activated implants: cardiac pacemakers/defibrillator, biostimulators, neurostimulators, cochlear implants, hearing aids, insulin pump; claustrophobia)
* Subjects who are familiar and have played on multiple occasions the computer game "need for speed"

Primary outcomes:
measure: seeing evidence of microstructural brain tissue changes in Diffusion Tensor Imaging (DTI) MRI
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Movement Disorders Institute, Sheba Medical center
Study officials:
affiliation: Sheba Medical Center
name: Sharon Hassin-Baer, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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