NCT01151111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started May 2010

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

2 years

First QC Date

May 18, 2010

Last Update Submit

May 7, 2014

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseRelaxationVisual imageryMotor fluctuationsTreatment

Outcome Measures

Primary Outcomes (1)

  • 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

    30 minutes

Secondary Outcomes (7)

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

    2 weeks

  • Change from baseline to week 2 in PDQ39

    2 weeks

  • Change from baseline to minutes 30 of Unified Parkinson's Disease Rating Scale (UPDRS) after relaxing music

    30 minutes

  • Change from baseline to week 2 in the number of OFF hours

    2 weeks

  • Change from baseline to month 3 in PDQ39

    3 months

  • +2 more secondary outcomes

Interventions

Relaxation guided imageryBEHAVIORAL

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.

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Dementia
  • hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ilana Schleainger

Haifa, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Ilana Schlesinger, M.D.

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Movement Disorders Institute

Study Record Dates

First Submitted

May 18, 2010

First Posted

June 25, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2014

Last Updated

May 8, 2014

Record last verified: 2014-05

Locations

IL(1)