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Training the brain with virtual reality treadmill training to enhance mobility and reduce falls in elderly with Parkinson's Disease.


- candidate number14035
- NTR NumberNTR3723
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-nov-2012
- Secondary IDsNL41661.091.12/NCT01732653 CMO region Arnhem/Nijmegen / ClinicalTrials.gov (this trial is part of the V-TIME project)
- Public TitleTraining the brain with virtual reality treadmill training to enhance mobility and reduce falls in elderly with Parkinson's Disease.
- Scientific TitleNeural correlates of plasticity in a Virtual reality-Treadmill combined Intervention for enhancing Mobility and reducing falls in Elderly (V-TIME) with Parkinson's Disease.
- ACRONYMV-TIME neural plasticity study
- hypothesisPrevious work showed that a shift in functional connectivity from the posterior to the anterior putamen can be seen in PD patients (Helmich et al. 2010). Thus, PD patients probably use their anterior putamen for both cognitive and simple motor tasks. In healthy persons, cognitive tasks mostly rely on the anterior putamen whereas simple motor tasks mostly rely on the posterior putamen. We hypothesize that a bottleneck in the anterior putamen causes reduced dual task performance in PD patients. Through the VR training, we expect to see compensation for this bottleneck in other brain regions. Thus, we hypothesise that treadmill training with VR will cause a partial shift of cognitive control from the anterior putamen towards other brain regions such as the anterior cingulated cortex, the nucleus caudatus and the prefrontal cortex.
- Healt Condition(s) or Problem(s) studiedParkinson's disease
- Inclusion criteria1. At least 2 falls within the 6 months prior to the study;
2. Age range: 60-85 years;
3. Diagnosis of PD (UK Parkinson's Disease Society Brain Bank: UKBB);
4. Hoehn and Yahr stage II-III (on medication);
5. Stable medication for at least one month and anticipated for the next 6 months;
6. Able to walk at least 5 minutes unassisted;
7. Adequate hearing and vision.
- Exclusion criteria1. Psychiatric co-morbidities (e.g., major depression - Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria);
2. Clinical diagnosis of dementia (e.g., Alzheimer's, vascular, etc.);
3. History of stroke, traumatic brain injury, brain tumour or other neurological disorders;
4. Acute lower back or lower extremity pain, musculoskeletal injuries, peripheral neuropathy which restricts gait;
5. Unstable medical condition including cardiovascular instability in past 6 months;
6. Unable to comply with training;
7. Cognitively impaired (< 24 on Mini-Mental State Examination);
8. Interfering therapy, or fall clinic visit <1 months ago;
9. Severe freezing precluding safe participation (>15 on New Freezing of Gait Questionnaire);
10. Metal objects or fragments in/on body;
11. Active implant (e.g. pacemaker, neurostimulator, insulin pump);
12. Epilepsy;
13. Claustrophobia.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate1-jun-2015
- Target number of participants90
- InterventionsAt RUNMC (Nijmegen) 50 patients with PD will be randomized into one of these two groups:
1. Treadmill Training with Virtual Reality (TT+VR) for 12 weeks, three times per week;
2. Active control comparison of Treadmill Training alone (TT), 12 weeks, three times per week.

At TASMC (Tel Aviv) 40 patients with PD will be randomized into one of these two groups:
1. Treadmill Training with Virtual Reality (TT+VR) for 6 weeks, three times per week;
2. Active control comparison of Treadmill Training alone (TT), 6 weeks, three times per week.
- Primary outcomeThe main study parameter is the change in blood oxygenation level dependent (BOLD) signal in the bilateral anterior putamen during performance of a dual task containing a lower limb motor task and a cognitive task (functional MRI, pre-training vs. post-training assessment).
- Secondary outcomeSecondary study parameters include the change in blood oxygenation level dependent (BOLD) signal in the bilateral caudate nucleus, the anterior cingulate cortex and the prefrontal cortex, during performance of a dual task containing a lower limb motor task and a cognitive task (fMRI, pre-training vs. post-training assessment). Other secondary study parameters are prefrontal cortex activation (concentration of oxygenated and deoxygenated heamoglobin) during training and more general walking tasks (functional near infrared spectroscopy fNIRS; dual task walking, obstacle negotiation, walking at preferred speed). Also, magnetic resonance imaging will be used to obtain brain oxygenation levels during ankle movements and a cognitive task, resting state functional connectivity, grey matter volume and white matter integrity. Other secondary study parameters are measures of gait, fall frequency, balance and mobility, community ambulation, cognitive functioning, health related quality of life, fear of falling and user satisfaction of the intervention. A pre-training vs. post training assessment will be used for all secondary study parameters.
- TimepointsPre assessment (all outcome measures), intermediate assessments after 4 weeks (physical and mental functioning) and 6 weeks (physical and mental functioning and fNIRS) of training, post assessment (all outcome measures), 1 and 6 month follow up assessments (all outcome measures besides (f)MRI and fNIRS).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc. Freek Nieuwhof
- CONTACT for SCIENTIFIC QUERIESMSc. Freek Nieuwhof
- Sponsor/Initiator Radboud University Nijmegen Medical Centre
- Funding
(Source(s) of Monetary or Material Support)
European Union
- PublicationsN/A
- Brief summaryIn this trial, which is part of the Seventh Framework program V-TIME, neural correlates of plasticity of the V-TIME fall prevention intervention are investigated.
- Main changes (audit trail)
- RECORD27-nov-2012 - 6-dec-2012


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