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Parkinson's DiseaseEarly Phase 1NCT01151111

Relaxation Guided Imagery for Treatment of Parkinson's Disease

A Early Phase 1 study testing Relaxation guided imagery in people with Parkinson's Disease, run by Rambam Health Care Campus at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
Relaxation guided imagery
How many people
20 participants
Where
1 siteIsrael
Study dates
May 2010to May 2014
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Dementia
  • hearing impairment

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Ilana Schleainger

    Haifa

Other trials in Israel

About this study

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

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.

Read the 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.

Being tested
Relaxation guided imagery
Keywords
Parkinson's disease, Relaxation, Visual imagery, Motor fluctuations, Treatment
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Relaxation guided imageryBehavioural

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 minutes

Secondary outcomes (7)

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

    Patient will fill out a CGI

    Measured: 2 weeks

  2. Change from baseline to week 2 in PDQ39

    PDQ39 questionaire will be filled out by the patient

    Measured: 2 weeks

  3. 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

    Measured: 30 minutes

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

    The mean number of daily OFF hours over 3 days after visit.

    Measured: 2 weeks

  5. Change from baseline to month 3 in PDQ39

    PDQ39 questionaire will be filled out by the patient

    Measured: 3 months

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

    Patient will fill out a CGI

    Measured: 3 months

  7. Change from baseline to week 1 in the number of OFF hours

    The mean number of daily OFF hours over 3 days after visit

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionMay 2012
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01151111
Sponsor's protocol ID
0457-09-RMB
Status last verified
May 2014
First submitted
18 May 2010
Last updated
8 May 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Relaxation guided imagery in people with Parkinson's Disease, run by Rambam Health Care Campus at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of Unified Parkinson's Disease Rating Scale (UPDRS) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01151111.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2014.

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