Relaxation Guided Imagery for Treatment of Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151111
• Other study ID #: 0457-09-RMB
• Status: Completed
• Phase: Phase 0
• First received: May 18, 2010
• Last updated: May 7, 2014
• Start date: May 2010
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Patients with idiopathic Parkinson's disease suffering from motor fluctuations

• H&Y >2

Exclusion Criteria:

• Dementia

• hearing impairment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
Israel	Ilana Schleainger	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline to week 2 in Clinical Global Impression Scale (CGI)	Patient will fill out a CGI	2 weeks	No
Secondary	Change from baseline to week 2 in PDQ39	PDQ39 questionaire will be filled out by the patient	2 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Change from baseline to month 3 in PDQ39	PDQ39 questionaire will be filled out by the patient	3 months	No
Secondary	Change from baseline to month 3 in Clinical Global Impression Scale (CGI)	Patient will fill out a CGI	3 months	No
Secondary	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	No