NCT02494908

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 10, 2015

Status Verified

July 1, 2015

Enrollment Period

2.5 years

First QC Date

July 8, 2015

Last Update Submit

July 9, 2015

Conditions

Parkinson Disease

Keywords

Parkinson DiseaseMRI

Outcome Measures

Primary Outcomes (1)

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

    2 hours

Study Arms (2)

Healthy controls

ACTIVE COMPARATOR

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

IPD patients

ACTIVE COMPARATOR

Men and women diagnosed with idiopathic parkinson's disease

Behavioral: Playing a computer game simulating a car race

Interventions

Playing a computer game simulating a car raceBEHAVIORAL

Playing a computer game simulating a car race

Healthy controlsIPD patients

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Movement Disorders Institute, Sheba Medical center

Ramat Gan, 5265601, Israel

Location

Related Publications (10)

  • 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.

    PMID: 22445346BACKGROUND

  • 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.

    PMID: 9800094BACKGROUND

  • 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.

    PMID: 12464697BACKGROUND

  • 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.

    PMID: 19061920BACKGROUND

  • 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.

    PMID: 22087090BACKGROUND

  • 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.

    PMID: 23904619BACKGROUND

  • 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.

    PMID: 24336705BACKGROUND

  • 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.

    PMID: 21945835BACKGROUND

  • 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.

    PMID: 25725909BACKGROUND

  • 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.

    PMID: 21701690BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Sharon Hassin-Baer, Dr

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vered Livneh, Dr

CONTACT

03-5304931vered.livneh@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 10, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2018

Study Completion

July 1, 2018

Last Updated

July 10, 2015

Record last verified: 2015-07

Locations

IL(1)