An Early Phase 1 interventional study of Relaxation guided imagery in Parkinson's Disease, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2014-05-08.
Sponsored by Rambam Health Care Campus · Early Phase 1, Interventional, and Treatment
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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Exclusion Criteria:
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.
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
Time frame: 30 minutes
Change from baseline to week 2 in Clinical Global Impression Scale (CGI)
Patient will fill out a CGI
Time frame: 2 weeks
Change from baseline to week 2 in PDQ39
PDQ39 questionaire will be filled out by the patient
Time frame: 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
Time frame: 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.
Time frame: 2 weeks
Change from baseline to month 3 in PDQ39
PDQ39 questionaire will be filled out by the patient
Time frame: 3 months
Change from baseline to month 3 in Clinical Global Impression Scale (CGI)
Patient will fill out a CGI
Time frame: 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
Time frame: 1 week
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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