Relaxation Guided Imagery for Treatment of Parkinson's Disease

Early Phase 1

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT01151111
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Primary Completion: 2012-05
• Status Verified: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-07
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with idiopathic Parkinson's disease suffering from motor fluctuations
• H&Y >2

Exclusion Criteria

• Dementia
• hearing impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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

Trial Locations

Locations (1)

Ilana Schleainger; 🇮🇱 Haifa, Israel