Parkinson DiseaseNCT02494908
Evidence of Neuroplasticity After Performing a Cognitive Task in Idiopathic Parkinson's Disease Patients
A study testing Playing a computer game simulating a car race in people with Parkinson Disease, run by Dr. Sharon Hassin at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Playing a computer game simulating a car race
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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"
Trial locations and contacts
1 site in 1 country.
Israel1 site
Movement Disorders Institute, Sheba Medical center
Ramat Gan, 5265601
Vered Livneh, Dr., +972-3-5304931, vered.livneh@gmail.com
Esther Stein, +972-3-5304931, Esther.Stein@sheba.health.gov.il
About this study
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 ?
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.
Read the 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).
- Conditions
- Parkinson Disease
- Being tested
- Playing a computer game simulating a car race
- Keywords
- Parkinson Disease, MRI
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Playing a computer game simulating a car raceBehavioural
Playing a computer game simulating a car race
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Active comparator | Healthy controls with no known neurological disease matched for sex and age with the patients group Receives: Behavioral: Playing a computer game simulating a car race |
| IPD patients | Active comparator | Men and women diagnosed with idiopathic parkinson's disease Receives: Behavioral: Playing a computer game simulating a car race |
What is being measured
The primary outcome is the main question the study is designed to answer.
seeing evidence of microstructural brain tissue changes in Diffusion Tensor Imaging (DTI) MRI
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Sharon Hassin
- Sponsor type
- Other government
- Collaborators
- Bar-Ilan University, Israel, Tel Aviv University, Sheba Medical Center
- Responsible party
- Sponsor-investigator, Dr. Sharon Hassin, Sheba Medical Center
- Investigators
- Sharon Hassin-Baer, Dr, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494908
- Sponsor's protocol ID
- 2372-15-SMC
- Status last verified
- Jul 2015
- First submitted
- 8 Jul 2015
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22445346Vakil 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.
PubMed 9800094Exner 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.
PubMed 12464697Doyon 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.
PubMed 19061920Gheysen 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.
PubMed 22087090Hofstetter 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.
PubMed 23904619Hill 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.
PubMed 24336705Foerde 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.
PubMed 21945835Schlaug 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.
PubMed 25725909Blumenfeld-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.
PubMed 21701690
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 ?
- ClinicalTrials.gov ID
- NCT02494908
- Acronym / sponsor ID
- 2372-15-SMC
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dr. Sharon HassinOther government
- Collaborators
- Bar-Ilan University, Israel, Tel Aviv University, Sheba Medical Center
- Study start
- Jul 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Active comparator | Behavioral: Playing a computer game simulating a car raceHealthy controls with no known neurological disease matched for sex and age with the patients group |
| IPD patients | Active comparator | Behavioral: Playing a computer game simulating a car raceMen and women diagnosed with idiopathic parkinson's disease |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Playing a computer game simulating a car racePlaying a computer game simulating a car race | Behavioural | Healthy controls, IPD patients |
Primary outcome
seeing evidence of microstructural brain tissue changes in Diffusion Tensor Imaging (DTI) MRI
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
- Background: PubMed 22445346Sagi 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.
- Background: PubMed 9800094Vakil 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.
- Background: PubMed 12464697Exner 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.
- Background: PubMed 19061920Doyon 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.
- Background: PubMed 22087090Gheysen 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.
- Background: PubMed 23904619Hofstetter 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.
- Background: PubMed 24336705Hill 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.
- Background: PubMed 21945835Foerde 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.
- Background: PubMed 25725909Schlaug 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.
- Background: PubMed 21701690Blumenfeld-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Hassin-Baer, Dr principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Playing a computer game simulating a car race in people with Parkinson Disease, run by Dr. Sharon Hassin at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vered Livneh, Dr (03-5304931, vered.livneh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seeing evidence of microstructural brain tissue changes in Diffusion Tensor Imaging (DTI) MRI (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02494908, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2015.