Back to resultsRelaxation Guided Imagery for Treatment of Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Early Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Relaxation guided imagery
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Relaxation, Visual imagery, Motor fluctuations, Treatment
Eligibility Criteria
Inclusion Criteria:
- Patients with idiopathic Parkinson's disease suffering from motor fluctuations
- H&Y >2
Exclusion Criteria:
- Dementia
- hearing impairment
Sites / Locations
- Ilana Schleainger
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change from baseline to week 2 in Clinical Global Impression Scale (CGI)
Patient will fill out a CGI
Change from baseline to week 2 in PDQ39
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
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
The mean number of daily OFF hours over 3 days after visit.
Change from baseline to month 3 in PDQ39
PDQ39 questionaire will be filled out by the patient
Change from baseline to month 3 in Clinical Global Impression Scale (CGI)
Patient will fill out a CGI
Change from baseline to week 1 in the number of OFF hours
The mean number of daily OFF hours over 3 days after visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01151111
Brief Title
Relaxation Guided Imagery for Treatment of Parkinson's Disease
Official Title
Pilot Study of Relaxation Guided Imagery for the Treatment of Motor Fluctuations in Parkinson's Disease's
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Relaxation, Visual imagery, Motor fluctuations, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Relaxation guided imagery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline of Unified Parkinson's Disease Rating Scale (UPDRS)
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline to week 2 in Clinical Global Impression Scale (CGI)
Description
Patient will fill out a CGI
Time Frame
2 weeks
Title
Change from baseline to week 2 in PDQ39
Description
PDQ39 questionaire will be filled out by the patient
Time Frame
2 weeks
Title
Change from baseline to minutes 30 of Unified Parkinson's Disease Rating Scale (UPDRS) after relaxing music
Description
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
Title
Change from baseline to week 2 in the number of OFF hours
Description
The mean number of daily OFF hours over 3 days after visit.
Time Frame
2 weeks
Title
Change from baseline to month 3 in PDQ39
Description
PDQ39 questionaire will be filled out by the patient
Time Frame
3 months
Title
Change from baseline to month 3 in Clinical Global Impression Scale (CGI)
Description
Patient will fill out a CGI
Time Frame
3 months
Title
Change from baseline to week 1 in the number of OFF hours
Description
The mean number of daily OFF hours over 3 days after visit
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with idiopathic Parkinson's disease suffering from motor fluctuations
H&Y >2
Exclusion Criteria:
Dementia
hearing impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilana Schlesinger, M.D.
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ilana Schleainger
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Relaxation Guided Imagery for Treatment of Parkinson's Disease
We'll reach out to this number within 24 hrs