NCT02589925

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

4.3 years

First QC Date

September 28, 2015

Last Update Submit

May 20, 2020

Conditions

Parkinson DiseaseDementia

Keywords

deep brain stimulationsubthalamic nucleusNucleus basalis Meynert

Outcome Measures

Primary Outcomes (1)

  • safety as determined by spontaneously reported adverse events

    Safety of combined bilateral subthalamic nucleus (STN) and basal nucleus of Meynert (NBM) stimulation as determined by spontaneously reported adverse events

    48 weeks

Other Outcomes (15)

  • Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)

    48 weeks

  • Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADAS-CGIC)

    48 weeks

  • Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL)

    48 weeks

  • +12 more other outcomes

Study Arms (2)

sham stimulation

SHAM COMPARATOR

ineffective neurostimulation of the Nucleus basalis Meynert combined with subthalamic nucleus (STN) stimulation using Vercise deep brain stimulation

Device: Vercise deep brain stimulationProcedure: subthalamic nucleus (STN) stimulationProcedure: sham stimulation

NBM stimulation

ACTIVE COMPARATOR

effective neurostimulation of the Nucleus basalis Meynert combined with subthalamic nucleus (STN) stimulation using Vercise deep brain stimulation

Device: Vercise deep brain stimulationProcedure: subthalamic nucleus (STN) stimulationProcedure: NBM stimulation

Interventions

Vercise deep brain stimulationDEVICE

implantation of a Vercise neurostimulation system

NBM stimulationsham stimulation
subthalamic nucleus (STN) stimulationPROCEDURE

bilateral high-frequency neurostimulation of the subthalamic nucleus using a Vercise neurostimulation system

NBM stimulationsham stimulation
NBM stimulationPROCEDURE

bilateral low-frequency neurostimulation of the subthalamic nucleus using a Vercise neurostimulation system

NBM stimulation
sham stimulationPROCEDURE

ineffective neurostimulation by setting 0mA output at the Vercise neurostimulation system

sham stimulation

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age at the time of enrollment: 35 - 75 years.
  • Diagnosis of idiopathic PD with probable Parkinson's disease dementia (PDD) as defined by the MDS consensus guidelines (Emre et al., 2007)
  • Mild to moderately severe dementia as defined by a Mini-Mental State Examination (MMSE) score of 10 to 24
  • Duration of bilateral idiopathic PD: ≥5 years of motor symptoms.
  • Severity of bilateral idiopathic PD in the meds off state: modified Hoehn and Yahr stage ≥2.
  • UPDRS subset III score of ≥30 in the meds off, stim off state.
  • Levodopa must improve PD symptoms by ≥30% in a levodopa challenge test, as measured by UPDRS subset III score.
  • PDD with a symptom onset at least 2 years after first symptoms of PD
  • 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.
  • 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

You may not qualify if:

  • Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression.
  • Any current drug or alcohol abuse.
  • Any history of recurrent or unprovoked seizures.
  • Any prior movement disorder treatments that involved intracranial surgery or device implantation.
  • A history of neurostimulation intolerance in any area of the body.
  • 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.
  • 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.
  • Pregnancy, breast-feeding, or lack of reliable contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Würzburg, Department of Neurology

Würzburg, 97080, Germany

Location

Related Publications (1)

  • Daniels C, Steigerwald F, Capetian P, Matthies C, Malzahn U, Heuschmann PU, Volkmann J. Combined subthalamic and nucleus basalis of Meynert deep brain stimulation for Parkinson's disease with dementia (DEMPARK-DBS): protocol of a randomized, sham-controlled trial. Neurol Res Pract. 2020 Oct 19;2:41. doi: 10.1186/s42466-020-00086-w. eCollection 2020.

    PMID: 33324941DERIVED

MeSH Terms

Conditions

Parkinson DiseaseDementia

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Jens Volkmann, MD, PhD

    Wuerzburg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2015

First Posted

October 28, 2015

Study Start

October 1, 2016

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

May 22, 2020

Record last verified: 2020-05

Locations

DE(1)