Clinical trial NCT01151111: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Relaxation
Visual imagery
Motor fluctuations
Treatment
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-06-25
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Dementia
* hearing impairment

Primary outcomes:
measure: Change from baseline of Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 30 minutes
Secondary outcomes:
measure: Change from baseline to week 2 in Clinical Global Impression Scale (CGI)
timeFrame: 2 weeks
measure: Change from baseline to week 2 in PDQ39
timeFrame: 2 weeks
measure: Change from baseline to minutes 30 of Unified Parkinson's Disease Rating Scale (UPDRS) after relaxing music
timeFrame: 30 minutes
measure: Change from baseline to week 2 in the number of OFF hours
timeFrame: 2 weeks
measure: Change from baseline to month 3 in PDQ39
timeFrame: 3 months
measure: Change from baseline to month 3 in Clinical Global Impression Scale (CGI)
timeFrame: 3 months
measure: Change from baseline to week 1 in the number of OFF hours
timeFrame: 1 week
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Ilana Schleainger
Study officials:
affiliation: Rambam Health Care Campus
name: Ilana Schlesinger, M.D.
role: PRINCIPAL_INVESTIGATOR
References: