ClinicalTrials.gov
ClinicalTrials.gov Menu

Combined Subthalamic and Nucleus Basalis Meynert Deep Brain Stimulation for Parkinson's Disease With Dementia (Dempark-DBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02589925
Recruitment Status : Recruiting
First Posted : October 28, 2015
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wuerzburg University Hospital

Brief Summary:
Phase 1 study evaluating the safety of combined bilateral subthalamic nucleus (STN) and basal nucleus of Meynert (NBM) stimulation in treating levodopa responsive motor symptoms of Parkinsonism and cognitive dysfunction in patients with advanced Parkinson's disease having mild to moderate dementia.

Condition or disease Intervention/treatment Phase
Parkinson Disease Dementia Device: Vercise deep brain stimulation Procedure: subthalamic nucleus (STN) stimulation Procedure: NBM stimulation Procedure: sham stimulation Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Kombinierte Tiefe Hirnstimulation Des Nucleus Subthalamicus Und Nucleus Basalis Meynert Zur Behandlung Der Parkinson-Krankheit Mit Demenz
Actual Study Start Date : October 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: sham stimulation
ineffective neurostimulation of the Nucleus basalis Meynert combined with subthalamic nucleus (STN) stimulation using Vercise deep brain stimulation
Device: Vercise deep brain stimulation
implantation of a Vercise neurostimulation system

Procedure: subthalamic nucleus (STN) stimulation
bilateral high-frequency neurostimulation of the subthalamic nucleus using a Vercise neurostimulation system

Procedure: sham stimulation
ineffective neurostimulation by setting 0mA output at the Vercise neurostimulation system

Active Comparator: NBM stimulation
effective neurostimulation of the Nucleus basalis Meynert combined with subthalamic nucleus (STN) stimulation using Vercise deep brain stimulation
Device: Vercise deep brain stimulation
implantation of a Vercise neurostimulation system

Procedure: subthalamic nucleus (STN) stimulation
bilateral high-frequency neurostimulation of the subthalamic nucleus using a Vercise neurostimulation system

Procedure: NBM stimulation
bilateral low-frequency neurostimulation of the subthalamic nucleus using a Vercise neurostimulation system




Primary Outcome Measures :
  1. safety as determined by spontaneously reported adverse events [ Time Frame: 48 weeks ]
    Safety of combined bilateral subthalamic nucleus (STN) and basal nucleus of Meynert (NBM) stimulation as determined by spontaneously reported adverse events


Other Outcome Measures:
  1. Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) [ Time Frame: 48 weeks ]
  2. Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADAS-CGIC) [ Time Frame: 48 weeks ]
  3. Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: 48 weeks ]
  4. Unified Parkinson's Disease Rating Scale section II (UPDRS II) [ Time Frame: 48 weeks ]
    Unified Parkinson's Disease Rating Scale section II

  5. Beck Depression Inventory (BDI) [ Time Frame: 48 weeks ]
  6. Neuropsychiatric Inventory (NPI) [ Time Frame: 48 weeks ]
  7. Verbal Fluency [ Time Frame: 48 weeks ]
    Combined verbal fluency score from D-KEFS battery, Wisconsin Card Sorting Test (modified version), Trail Making Task Part A + B, Stroop Test (Victoria Version), Symbol Digit Modalities Test

  8. Brief Test of Attention [ Time Frame: 48 weeks ]
    auditory perception task that measures divided attention in the verbal-linguistic system

  9. Starkstein Apathy Scale [ Time Frame: 48 weeks ]
  10. Unified Parkinson's Disease Rating Scale section III (UPDRS III) [ Time Frame: 48 weeks ]
  11. Clinical Dyskinesia Rating Scale (CDRS) [ Time Frame: 48 weeks ]
  12. EQ-5d [ Time Frame: 48 weeks ]
    EQ-5D questionnaire of the EuroQol-group

  13. Parkinson's Disease Questionnaire for quality of life (PDQ39) [ Time Frame: 48 weeks ]
  14. Caregiver burden assessment/SF36 [ Time Frame: 48 weeks ]
  15. Direct and indirect costs [ Time Frame: 48 weeks ]
    cost of treatment, loss of caregiver productivity, loss of patient productivity, etc.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age at the time of enrollment: 35 - 75 years.
  2. Diagnosis of idiopathic PD with probable Parkinson's disease dementia (PDD) as defined by the MDS consensus guidelines (Emre et al., 2007)
  3. Mild to moderately severe dementia as defined by a Mini-Mental State Examination (MMSE) score of 10 to 24
  4. Duration of bilateral idiopathic PD: ≥5 years of motor symptoms.
  5. Severity of bilateral idiopathic PD in the meds off state: modified Hoehn and Yahr stage ≥2.
  6. UPDRS subset III score of ≥30 in the meds off, stim off state.
  7. Levodopa must improve PD symptoms by ≥30% in a levodopa challenge test, as measured by UPDRS subset III score.
  8. PDD with a symptom onset at least 2 years after first symptoms of PD
  9. Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging systems and completing the motor diary) if mentally competent or, if incompetent, their legally authorized representatives.
  10. Able to understand the study requirements and the treatment procedures and to provide written informed consent before any study-specific tests or procedures are performed. If mentally incompetent, the legally authorized representative provides written informed consent

Exclusion Criteria:

  1. Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression.
  2. Any current drug or alcohol abuse.
  3. Any history of recurrent or unprovoked seizures.
  4. Any prior movement disorder treatments that involved intracranial surgery or device implantation.
  5. A history of neurostimulation intolerance in any area of the body.
  6. Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
  7. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
  8. Pregnancy, breast-feeding, or lack of reliable contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589925


Contacts
Contact: Jens Volkmann, MD, PhD 0931-201 ext 23751 NL_direktion@ukw.de

Locations
Germany
University Hospital Würzburg, Department of Neurology Recruiting
Würzburg, Germany, 97080
Contact: Jens Volkmann, MD, PhD    +49931-201 ext 23751    NL_direktion@ukw.de   
Principal Investigator: Jens Volkmann, MD, PhD         
Sponsors and Collaborators
Wuerzburg University Hospital
Investigators
Principal Investigator: Jens Volkmann, MD, PhD Wuerzburg University Hospital

Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT02589925     History of Changes
Other Study ID Numbers: DEMPARK-DBS V2.01
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Keywords provided by Wuerzburg University Hospital:
deep brain stimulation
subthalamic nucleus
Nucleus basalis Meynert

Additional relevant MeSH terms:
Parkinson Disease
Dementia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders