Clinical trial NCT03637023: Virtual Reality for Parkinson's Disease
Official title: Clinical and Rest-fMRI Effects of Virtual Reality Practice on Motor and Cognitive Symptoms in Parkinson's Disease, a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Virtual Reality Therapy
Functional Magnetic Resonance Imaging
Keywords: fMRI
Virtual Reality Therapy
Exercise Therapy
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parkinson's Disease (PD) is one of the most common neurodegenerative disease. Bradykinesia, tremor, resting tremor and postural instability are the main motor characteristics of this disease. As the disease progresses, mobility, walking, balance are reducing, the risk of falls is increasing and patients become functionally dependent. Along with these symptoms, cognitive functions are also disturbed. The most commonly distorted cognitive functions are executive functions such as planning and reasoning, working memory, episodic memory, attention and visual-spatial skills. Pharmacological and surgical treatments are used in Parkinson's disease. Pharmacologic treatment has a proven effect on motor symptoms, but since there is no approved pharmacologic treatment which has a direct effect on cognitive functions, recent studies suggest non-pharmacological treatments to improve cognitive function. Physiotherapy is also accepted among non-pharmacological treatments. Conventional physiotherapy focuses on optimizing patient independence and safety, focusing on hinting strategies, cognitive movement strategies and exercises utilizing transfers, posture, upper extremity function, balance (and falls), gait, physical capacity and (in)activity. Virtual Reality (VR) technology, a promising commonly used new rehabilitation tool, is a treatment method that can be used as one of the non-pharmacological treatment methods in Parkinson's Disease. In order to understand how neuronal network dysfunction in the Parkinson's Disease leads to clinical symptoms, both the component elements and the interconnections within these networks need to be examined in greater detail. Studies of resting state-fMRI (rs-fMRI) use correlation of activation of brain regions and time series fluctuations between brain regions to give information about connectivity in brain.

The purpose of this study is to investigate the therapeutic effects of virtual reality on motor and cognitive symptoms of PD. Furthermore, the investigation of possible effects of this effect on neuroplasticity through functional brain networks is our other objective. This study will be the first study to evaluate the plasticity effect of virtual reality application with rs-fMRI in Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* To be 50 years old and older
* Clinical diagnosis of PD within the -framework of Brain Bank criteria
* Getting a stable antiparkinsonian medication at least for the last 1 month (or the treatment has not changed)

Exclusion Criteria:

* Having a story of unstable medical condition
* History of head trauma, stroke, or exposure to toxic substances
* Implying Parkinson plus syndromes in neurological examinations; pyramidal, cerebellar examination findings, gaze paresis, autonomic dysfunction
* Being diagnosed with Dementia

Primary outcomes:
measure: Motor Level
timeFrame: Change from Baseline at 4 weeks.
measure: Cognitive Level
timeFrame: Change from Baseline at 4 weeks.
measure: Neuroplasticity
timeFrame: Change from Baseline at 4 weeks.
Secondary outcomes:
measure: Balance
timeFrame: Change from Baseline at 4 weeks.
measure: Quality of Life in patients with Parkinson's Disease
timeFrame: Change from Baseline at 4 weeks.
measure: Mobility
timeFrame: Change from Baseline at 4 weeks.
measure: Functional Capacity
timeFrame: Change from Baseline at 4 weeks.
measure: Depression
timeFrame: Change from Baseline at 4 weeks.
measure: Balance Confidence
timeFrame: Change from Baseline at 4 weeks.
measure: Cognitive Assessment
timeFrame: Change from Baseline at 4 weeks.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Hospital
state: Bağcılar
Study officials:
affiliation: Medipol University
name: Farzin Hajebrahimi
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol University
name: Lutfu Hanoglu, Professor
role: STUDY_DIRECTOR
References:
citation: Dockx K, Bekkers EM, Van den Bergh V, Ginis P, Rochester L, Hausdorff JM, Mirelman A, Nieuwboer A. Virtual reality for rehabilitation in Parkinson's disease. Cochrane Database Syst Rev. 2016 Dec 21;12(12):CD010760. doi: 10.1002/14651858.CD010760.pub2.