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

June 6, 2013 updated by: Jens Kuhn, University of Cologne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine Westphalia
      • Cologne, North Rhine Westphalia, Germany, 50924
        • Uni-Klinik Köln AöR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Placebo
Stimulator setting is OFF
Other: Deep brain stimulation
DBS in the Nucleus basalis Meynert
Active Comparator: Deep Brain Stimulation
Stimulator setting is ON
Other: Deep brain stimulation
DBS in the Nucleus basalis Meynert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive improvement
Time Frame: one- year
improving cognitive outcome parameters assessed by a series of standardized neuropsychological tests
one- year

Secondary Outcome Measures

Outcome Measure
Time Frame
determination of the optimal stimulation parameter
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Volker Sturm, MD, University of Cologne
  • Principal Investigator: Jens Kuhn, MD, University of Cologne
  • Principal Investigator: H. J. Freund, Prof. Dr. med., Stellvertretender Leiter der Klinischen Prüfung Institut für Neurowissenschaften und Medizin (INM-7) Forschungszentrum Jülich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 25, 2010

First Submitted That Met QC Criteria

March 25, 2010

First Posted (Estimate)

March 26, 2010

Study Record Updates

Last Update Posted (Estimate)

June 7, 2013

Last Update Submitted That Met QC Criteria

June 6, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UK-09157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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