Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Relaxation, Visual imagery, Motor fluctuations, Treatment
Brief summary
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
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.
Interventions
BEHAVIORALRelaxation 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.
Sponsors
Rambam Health Care Campus
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with idiopathic Parkinson's disease suffering from motor fluctuations * H&Y \>2
Exclusion criteria
* Dementia * hearing impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of Unified Parkinson's Disease Rating Scale (UPDRS) | 30 minutes | * Unified Parkinson's Disease Rating Scale (UPDRS) score after RGI as compared to baseline * OFF time after RGI as compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to week 2 in Clinical Global Impression Scale (CGI) | 2 weeks | Patient will fill out a CGI |
| Change from baseline to week 2 in PDQ39 | 2 weeks | PDQ39 questionaire will be filled out by the patient |
| Change from baseline to minutes 30 of Unified Parkinson's Disease Rating Scale (UPDRS) after relaxing music | 30 minutes | * Unified Parkinson's Disease Rating Scale (UPDRS) score after relaxing music as compared to baseline * OFF time after relaxing music as compared to baseline |
| Change from baseline to week 2 in the number of OFF hours | 2 weeks | The mean number of daily OFF hours over 3 days after visit. |
| Change from baseline to month 3 in PDQ39 | 3 months | PDQ39 questionaire will be filled out by the patient |
| Change from baseline to month 3 in Clinical Global Impression Scale (CGI) | 3 months | Patient will fill out a CGI |
| Change from baseline to week 1 in the number of OFF hours | 1 week | The mean number of daily OFF hours over 3 days after visit |
Countries
Israel
Outcome results
None listed