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

Parkinson Disease Clinical Trial

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 ?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02494908
• Other study ID #: 2372-15-SMC
• Status: Not yet recruiting
• Phase: N/A
• First received: July 8, 2015
• Last updated: July 9, 2015
• Start date: July 2015
• Est. completion date: July 2018

Study information

• Verified date: July 2015
• Source: Sheba Medical Center
• Contact: Vered Livneh, Dr
• Phone: 03-5304931
• Email: vered.livneh[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Playing a computer game simulating a car race
Playing a computer game simulating a car race

Locations

Country	Name	City	State
Israel	Movement Disorders Institute, Sheba Medical center	Ramat Gan

Sponsors (4)

Lead Sponsor	Collaborator
Dr. Sharon Hassin	Bar-Ilan University, Israel, Sheba Medical Center, Tel Aviv University

Country where clinical trial is conducted

Israel, 

References & Publications (10)

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. — View Citation

Doyon J, Bellec P, Amsel R, Penhune V, Monchi O, Carrier J, Lehéricy 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seeing evidence of microstructural brain tissue changes in Diffusion Tensor Imaging (DTI) MRI		2 hours	No