search
Back to results

Deep Brain Stimulation (DBS) of the Nucleus Basalis Meynert (NBM) to Treat Cognitive Deficits in Light to Moderate Alzheimer's Disease (MeynD-DBS)

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Deep brain stimulation
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring (light to moderate)

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • German speaking male/female subjects
  • age:60-80
  • AD assessed by DSM-IV, ICD-10 and NINCDS-ADRDA-Scale
  • no Lewy-Body-dementia or other form of dementia
  • MMST >18 and <26
  • stable psychopharmacological medication
  • no psychotic symptoms, no suicidal tendency
  • education for at least 8 years
  • written informed consent of the patient
  • consent of at least two family members
  • no contraindication regarding PET-examination
  • no contraindication regarding anesthesia or stereotactic operation

Exclusion Criteria:

  • legal accommodation
  • clinical co-morbidity
  • contraindication of MRT examination
  • psychotic symptoms last six months
  • aggressive behavior or suicidal tendency
  • verbal IQ <85
  • stereotactic operation in previous history
  • neoplastic neurological diseases
  • serious organic disease

Sites / Locations

  • Uni-Klinik Köln AöR

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Placebo

Deep Brain Stimulation

Arm Description

Stimulator setting is OFF

Stimulator setting is ON

Outcomes

Primary Outcome Measures

cognitive improvement
improving cognitive outcome parameters assessed by a series of standardized neuropsychological tests

Secondary Outcome Measures

determination of the optimal stimulation parameter

Full Information

First Posted
March 25, 2010
Last Updated
June 6, 2013
Sponsor
University of Cologne
search

1. Study Identification

Unique Protocol Identification Number
NCT01094145
Brief Title
Deep Brain Stimulation (DBS) of the Nucleus Basalis Meynert (NBM) to Treat Cognitive Deficits in Light to Moderate Alzheimer's Disease
Acronym
MeynD-DBS
Official Title
Deep Brain Stimulation of the Nucleus Basalis Meynert to Treat Cognitive Deficits in Light to Moderate Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In the study at hand, six patients with light to moderate Alzheimer's disease will be enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert.
Detailed Description
In the study at hand, six patients with light to moderate Alzheimer's disease will be enrolled and implanted with bilateral electrodes in the nucleus basalis Meynert. The stereotactic implantation of the electrodes will be guided by computerized tomography (CT) and magnetic resonance tomography (MRT). Basically, even though deep brain stimulation is an invasive method, there are only few side effects. Surgical risks correspond with the risk of DBS in morbus Parkinson or other movement disorders (0,4-6%). After the baseline examination, the patients will be implanted with the electrodes; accordingly all follow-ups are accomplished postoperative. From the second week after the operation, the conventional stimulation takes place as a doubleblind, randomized change between ON and OFF periods. Modifications of the stimulation parameter to obtain the best possible result are possible. Throughout the one-year observation-period, the patients will be followed closely to monitor the effects of DBS on their cognitive abilities, psychopathological well being, the quality of life, praxie and nutritional condition using standardized neurological and psychiatric rating scales.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
(light to moderate)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Stimulator setting is OFF
Arm Title
Deep Brain Stimulation
Arm Type
Active Comparator
Arm Description
Stimulator setting is ON
Intervention Type
Other
Intervention Name(s)
Deep brain stimulation
Intervention Description
DBS in the Nucleus basalis Meynert
Primary Outcome Measure Information:
Title
cognitive improvement
Description
improving cognitive outcome parameters assessed by a series of standardized neuropsychological tests
Time Frame
one- year
Secondary Outcome Measure Information:
Title
determination of the optimal stimulation parameter
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: German speaking male/female subjects age:60-80 AD assessed by DSM-IV, ICD-10 and NINCDS-ADRDA-Scale no Lewy-Body-dementia or other form of dementia MMST >18 and <26 stable psychopharmacological medication no psychotic symptoms, no suicidal tendency education for at least 8 years written informed consent of the patient consent of at least two family members no contraindication regarding PET-examination no contraindication regarding anesthesia or stereotactic operation Exclusion Criteria: legal accommodation clinical co-morbidity contraindication of MRT examination psychotic symptoms last six months aggressive behavior or suicidal tendency verbal IQ <85 stereotactic operation in previous history neoplastic neurological diseases serious organic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker Sturm, MD
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens Kuhn, MD
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
H. J. Freund, Prof. Dr. med.
Organizational Affiliation
Stellvertretender Leiter der Klinischen Prüfung Institut für Neurowissenschaften und Medizin (INM-7) Forschungszentrum Jülich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uni-Klinik Köln AöR
City
Cologne
State/Province
North Rhine Westphalia
ZIP/Postal Code
50924
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26827109
Citation
Baldermann JC, Schuller T, Huys D, Becker I, Timmermann L, Jessen F, Visser-Vandewalle V, Kuhn J. Deep Brain Stimulation for Tourette-Syndrome: A Systematic Review and Meta-Analysis. Brain Stimul. 2016 Mar-Apr;9(2):296-304. doi: 10.1016/j.brs.2015.11.005. Epub 2015 Dec 29.
Results Reference
derived

Learn more about this trial

Deep Brain Stimulation (DBS) of the Nucleus Basalis Meynert (NBM) to Treat Cognitive Deficits in Light to Moderate Alzheimer's Disease

We'll reach out to this number within 24 hrs