Relaxation Guided Imagery for Treatment of Parkinson's Disease

May 7, 2014 updated by: Ilana Schlesinger, Rambam Health Care Campus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Ilana Schleainger

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Dementia
  • hearing impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Ilana Schlesinger, M.D., Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

June 24, 2010

First Posted (Estimate)

June 25, 2010

Study Record Updates

Last Update Posted (Estimate)

May 8, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0457-09-RMB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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