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Completed

NCT Number: NCT01151111

Relaxation Guided Imagery for Treatment of Parkinson's Disease

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ilana Schleainger

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Dementia
  • hearing impairment

Treatment and study plan

Relaxation guided imagery

Behavioral

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 outcomes

  1. 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

Secondary outcomes

  1. Change from baseline to week 2 in Clinical Global Impression Scale (CGI)

    Time frame: 2 weeks

    Patient will fill out a CGI

  2. Change from baseline to week 2 in PDQ39

    Time frame: 2 weeks

    PDQ39 questionaire will be filled out by the patient

  3. 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

  4. 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.

  5. Change from baseline to month 3 in PDQ39

    Time frame: 3 months

    PDQ39 questionaire will be filled out by the patient

  6. Change from baseline to month 3 in Clinical Global Impression Scale (CGI)

    Time frame: 3 months

    Patient will fill out a CGI

  7. 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

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Jun 25, 2010
Registry last updated
May 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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