Relaxation Guided Imagery for Treatment of Parkinson's Disease

Study Overview
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Brief Summary
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Parkinson's disease patients may have pronounced ON-OFF motor fluctuations. These motor fluctuations are currently treated with medication and surgery, which are limited by their efficacy and side effects. Our study aims to determine whether relaxation guided imagery can alleviate the OFF state of PD patients and therefore can be used as an adjunct to conventional medication.

Detailed Description
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Parkinson's disease patients with pronounced ON-OFF motor fluctuations without dementia will participate in this study aimed to examine a possible beneficial effect of relaxation guided imagery on motor fluctuations. The study will include a baseline period two sessions of relaxation and a follow-up period. The relaxation sessions will be conducted individually. In one session patients will hear relaxing music and in the second they will undergo relaxation guided imagery. After each relaxation session patients will receive a CD with either relaxing music or RGI to listen to at home. They will be asked to fill out a diary at baseline and after each session. Before and after each relaxation session patients will be examined according to the Unified Parkinson's Disease Rating Scale and the examination will be videotaped. All patients will continue to receive the usual care from their medical providers. The main measure is change in UPDRS and secondary measure is change in daily OFF time.

Official Title
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Pilot Study of Relaxation Guided Imagery for the Treatment of Motor Fluctuations in Parkinson's Disease's

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: Relaxation guided imagery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with idiopathic Parkinson's disease suffering from motor fluctuations H&Y >2 Exclusion Criteria: Dementia hearing impairment

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Relaxation guided imagery|An individualized relaxation guided imagery session will be conducted. After the session patients will be given a CD with the RGI and asked to listen to it at home.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Unified Parkinson's Disease Rating Scale (UPDRS) | Unified Parkinson's Disease Rating Scale (UPDRS) score after RGI as compared to baseline OFF time after RGI as compared to baseline | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 2 in Clinical Global Impression Scale (CGI) | Patient will fill out a CGI | 2 weeks | 
| Change from baseline to week 2 in PDQ39 | PDQ39 questionaire will be filled out by the patient | 2 weeks | 
| Change from baseline to minutes 30 of Unified Parkinson's Disease Rating Scale (UPDRS) after relaxing music | Unified Parkinson's Disease Rating Scale (UPDRS) score after relaxing music as compared to baseline OFF time after relaxing music as compared to baseline | 30 minutes | 
| Change from baseline to week 2 in the number of OFF hours | The mean number of daily OFF hours over 3 days after visit. | 2 weeks | 
| Change from baseline to month 3 in PDQ39 | PDQ39 questionaire will be filled out by the patient | 3 months | 
| Change from baseline to month 3 in Clinical Global Impression Scale (CGI) | Patient will fill out a CGI | 3 months | 
| Change from baseline to week 1 in the number of OFF hours | The mean number of daily OFF hours over 3 days after visit | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Relaxation, Visual imagery, Motor fluctuations, Treatment