Back to results

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

Primary Purpose

Parkinson Disease

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Playing a computer game simulating a car race

About this trial

This is an interventional basic science trial for Parkinson Disease focused on measuring Parkinson Disease, MRI

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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"

Sites / Locations

Movement Disorders Institute, Sheba Medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Healthy controls

IPD patients

Arm Description

Healthy controls with no known neurological disease matched for sex and age with the patients group

Men and women diagnosed with idiopathic parkinson's disease

Outcomes

Primary Outcome Measures

seeing evidence of microstructural brain tissue changes in Diffusion Tensor Imaging (DTI) MRI

Secondary Outcome Measures

Full Information

NCT ID

NCT02494908

First Posted

July 8, 2015

Last Updated

July 9, 2015

Sponsor

Dr. Sharon Hassin

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02494908

Brief Title

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

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Sharon Hassin

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Parkinson Disease, MRI

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy controls

Arm Type

Active Comparator

Arm Description

Healthy controls with no known neurological disease matched for sex and age with the patients group

Arm Title

IPD patients

Arm Type

Active Comparator

Arm Description

Men and women diagnosed with idiopathic parkinson's disease

Intervention Type

Behavioral

Intervention Name(s)

Playing a computer game simulating a car race

Intervention Description

Playing a computer game simulating a car race

Primary Outcome Measure Information:

Title

seeing evidence of microstructural brain tissue changes in Diffusion Tensor Imaging (DTI) MRI

Time Frame

2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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"

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vered Livneh, Dr

Phone

03-5304931

vered.livneh@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharon Hassin-Baer, Dr

Organizational Affiliation

Sheba Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Movement Disorders Institute, Sheba Medical center

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vered Livneh, Dr.

Phone

+972-3-5304931

vered.livneh@gmail.com

First Name & Middle Initial & Last Name & Degree

Esther Stein

Phone

+972-3-5304931

Esther.Stein@sheba.health.gov.il

First Name & Middle Initial & Last Name & Degree

Vered Livneh, Dr.

First Name & Middle Initial & Last Name & Degree

Sharon Hassin-Baer, Dr.

12. IPD Sharing Statement

Citations:

PubMed Identifier

22445346

Citation

Sagi Y, Tavor I, Hofstetter S, Tzur-Moryosef S, Blumenfeld-Katzir T, Assaf Y. Learning in the fast lane: new insights into neuroplasticity. Neuron. 2012 Mar 22;73(6):1195-203. doi: 10.1016/j.neuron.2012.01.025. Epub 2012 Mar 21.

Results Reference

background

PubMed Identifier

9800094

Citation

Vakil E, Herishanu-Naaman S. Declarative and procedural learning in Parkinson's disease patients having tremor or bradykinesia as the predominant symptom. Cortex. 1998 Sep;34(4):611-20. doi: 10.1016/s0010-9452(08)70518-5.

Results Reference

background

PubMed Identifier

12464697

Citation

Exner C, Koschack J, Irle E. The differential role of premotor frontal cortex and basal ganglia in motor sequence learning: evidence from focal basal ganglia lesions. Learn Mem. 2002 Nov-Dec;9(6):376-86. doi: 10.1101/lm.48402.

Results Reference

background

PubMed Identifier

19061920

Citation

Doyon J, Bellec P, Amsel R, Penhune V, Monchi O, Carrier J, Lehericy S, Benali H. Contributions of the basal ganglia and functionally related brain structures to motor learning. Behav Brain Res. 2009 Apr 12;199(1):61-75. doi: 10.1016/j.bbr.2008.11.012. Epub 2008 Nov 17.

Results Reference

background

PubMed Identifier

22087090

Citation

Gheysen F, Van Opstal F, Roggeman C, Van Waelvelde H, Fias W. The neural basis of implicit perceptual sequence learning. Front Hum Neurosci. 2011 Nov 11;5:137. doi: 10.3389/fnhum.2011.00137. eCollection 2011.

Results Reference

background

PubMed Identifier

23904619

Citation

Hofstetter S, Tavor I, Tzur Moryosef S, Assaf Y. Short-term learning induces white matter plasticity in the fornix. J Neurosci. 2013 Jul 31;33(31):12844-50. doi: 10.1523/JNEUROSCI.4520-12.2013.

Results Reference

background

PubMed Identifier

24336705

Citation

Hill RA. Do short-term changes in white matter structure indicate learning-induced myelin plasticity? J Neurosci. 2013 Dec 11;33(50):19393-5. doi: 10.1523/JNEUROSCI.4122-13.2013. No abstract available.

Results Reference

background

PubMed Identifier

21945835

Citation

Foerde K, Shohamy D. The role of the basal ganglia in learning and memory: insight from Parkinson's disease. Neurobiol Learn Mem. 2011 Nov;96(4):624-36. doi: 10.1016/j.nlm.2011.08.006. Epub 2011 Sep 16.

Results Reference

background

PubMed Identifier

25725909

Citation

Schlaug G. Musicians and music making as a model for the study of brain plasticity. Prog Brain Res. 2015;217:37-55. doi: 10.1016/bs.pbr.2014.11.020. Epub 2015 Feb 11.

Results Reference

background

PubMed Identifier

21701690

Citation

Blumenfeld-Katzir T, Pasternak O, Dagan M, Assaf Y. Diffusion MRI of structural brain plasticity induced by a learning and memory task. PLoS One. 2011;6(6):e20678. doi: 10.1371/journal.pone.0020678. Epub 2011 Jun 20.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs