Evidence of Neuroplasticity After Performing a Cognitive Task in Idiopathic Parkinson's Disease Patients

July 9, 2015 updated by: Dr. Sharon Hassin

Can Diffusion Tensor MRI Brain Scan Demonstrate Microstructural Changes as Evidence of Neuroplasticity Following a Learning Process in Patients With Idiopathic Parkinson's Disease ?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Ramat Gan, Israel, 5265601
        • Movement Disorders Institute, Sheba Medical center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Vered Livneh, Dr.
        • Principal Investigator:
          • Sharon Hassin-Baer, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy controls
Healthy controls with no known neurological disease matched for sex and age with the patients group
Behavioral: Playing a computer game simulating a car race
Playing a computer game simulating a car race
Active Comparator: IPD patients
Men and women diagnosed with idiopathic parkinson's disease
Behavioral: Playing a computer game simulating a car race
Playing a computer game simulating a car race

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
seeing evidence of microstructural brain tissue changes in Diffusion Tensor Imaging (DTI) MRI
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Sharon Hassin

Collaborators

Tel Aviv University
Sheba Medical Center
Bar-Ilan University, Israel

Investigators

  • Principal Investigator: Sharon Hassin-Baer, Dr, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

July 9, 2015

First Posted (Estimate)

July 10, 2015

Study Record Updates

Last Update Posted (Estimate)

July 10, 2015

Last Update Submitted That Met QC Criteria

July 9, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2372-15-SMC

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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