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Mindfulness Based Intervention (MBI) on the Quality of Life and Non-Motor Symptoms (NMS) of Persons With Parkinson's Disease (PD)

This study is currently recruiting participants.
Verified May 2013 by University Hospital, Antwerp
Sponsor:
Collaborators:
DVE Consulting
Icometrix
Information provided by (Responsible Party):
Dr. Barbara A. Pickut, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01607697
First received: May 24, 2012
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  Purpose

Scientific Abstract:

The investigators propose a study to examine the impact of a Mindfulness Based Intervention (MBI) on the quality of life and Non-Motor Symptoms (NMS) of persons with Parkinson's disease (PD).

NMS add significantly to the disease burden and negatively impact the quality of life in PD (1,2). In a previous study the investigators confirmed the high prevalence of NMS in PD patients with either early- or late-onset of disease (3). Despite currently available treatments, PD leads to worsening disability and there remains a need for new approaches. A Mindfulness Based Intervention may provide an important adjuvant therapy in the treatment of PD in relation to NMS and quality of life.

A minimum of 100 patients will be randomly assigned to the MBI or 'Treatment As Usual' (TAU) groups. Clinical assessments (motor and non-motor scores) will be performed in both groups. The TAU group will be offered MBI after completion of the study.

To the best of our knowledge, this is the first large scale study using MBI in this indication.


Condition Intervention Phase
Parkinson's Disease
Non-Motor Symptoms of Parkinson's Disease
 Behavioral: Mindfulness Training
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Mindfulness Based Intervention (MBI) on the Quality of Life and Non-Motor Symptoms (NMS) of Persons With Parkinson's Disease (PD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Health Related Quality of Life (PDQ-39) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Depression Scale (Ham-D) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Structural and functional MRI pre- and post-MBI


Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Training Behavioral: Mindfulness Training
Mindfulness Training
Experimental: Waitlist Control Behavioral: Mindfulness Training
Mindfulness Training

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of PD according to the UK Brain Bank Criteria;
  • Patients in Hoehn & Yahr stage 1-3;
  • Lack of features suggestive of atypical Parkinsonism;
  • No history of neuroleptics or other drugs that induce parkinsonism in the last 60 days;
  • Currently optimally treated with medication and unlikely to be requiring anti-PD medication adjustments in the next 4 months;
  • On a stable dose of all medications for 30 days;
  • Lack of cognitive dysfunction as based on the MoCA (score ≥ 26).

Exclusion Criteria:

  • Cognitive dysfunction based on the MoCA (score < 26);
  • Patients with Hoehn & Yahr stage 4 and above when in 'on' stage;
  • Unstable, major psychiatric or life threatening concomitant disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607697

Contacts
Contact: Barbara A Pickut, MD, MPH +3238215212 barbara.pickut@ua.ac.be
Contact: Patrick Cras, MD, PhD +328215757 patrick.cras@ua.ac.be

Locations
Belgium
University Hospital Antwerp Recruiting
Antwerp, Belgium, 2650
Contact: Barbara A Pickut, MD, MPH     +3238215212     barbara.pickut@ua.ac.be    
Contact: Patrick Cras, MD, PhD     +3238215757     patrick.cras@ua.ac.be    
Principal Investigator: Barbara A Pickut, MD, MPH            
Sponsors and Collaborators
University Hospital, Antwerp
DVE Consulting
Icometrix
Investigators
Principal Investigator: Barbara A Pickut, MD, MPH Universiteit Antwerpen
  More Information

No publications provided

Responsible Party: Dr. Barbara A. Pickut, Clinical Chief Neurology and Neurorevalidation, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01607697     History of Changes
Other Study ID Numbers: B300201213369
Study First Received: May 24, 2012
Last Updated: May 20, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Antwerp:
Parkinson's Disease
Non-Motor Symptoms

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 May 22, 2013