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Relaxation Guided Imagery for Treatment of Parkinson's Disease

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01151111
First received: May 18, 2010
Last updated: June 24, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
 Behavioral: Relaxation guided imagery
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Relaxation Guided Imagery for the Treatment of Motor Fluctuations in Parkinson's Disease's

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Change from baseline of Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    • 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) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Patient will fill out a CGI

  • Change from baseline to week 2 in PDQ39 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The mean number of daily OFF hours over 3 days after visit.

  • Change from baseline to month 3 in PDQ39 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    PDQ39 questionaire will be filled out by the patient

  • Change from baseline to month 3 in Clinical Global Impression Scale (CGI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Patient will fill out a CGI

  • Change from baseline to week 1 in the number of OFF hours [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    The mean number of daily OFF hours over 3 days after visit


Estimated Enrollment: 20
Study Start Date: May 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Dementia
  • hearing impairment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01151111

Locations
Israel
Ilana Schleainger
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Ilana Schlesinger, M.D. Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Ilana Schleainger, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01151111     History of Changes
Other Study ID Numbers: 0457-09-RMB
Study First Received: May 18, 2010
Last Updated: June 24, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
Parkinson's disease
Relaxation
Visual imagery
Motor fluctuations
Treatment

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on June 18, 2013