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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jens Kuhn, University of Cologne
ClinicalTrials.gov Identifier:
NCT01094145
First received: March 25, 2010
Last updated: June 6, 2013
Last verified: June 2013

March 25, 2010
June 6, 2013
January 2010
January 2013   (final data collection date for primary outcome measure)
cognitive improvement [ Time Frame: one- year ] [ Designated as safety issue: No ]
improving cognitive outcome parameters assessed by a series of standardized neuropsychological tests
Same as current
Complete list of historical versions of study NCT01094145 on ClinicalTrials.gov Archive Site
determination of the optimal stimulation parameter [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Deep Brain Stimulation (DBS) of the Nucleus Basalis Meynert (NBM) to Treat Cognitive Deficits in Light to Moderate Alzheimer's Disease
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
Other: Deep brain stimulation
DBS in the Nucleus basalis Meynert
  • Sham Comparator: Placebo
    Stimulator setting is OFF
    Intervention: Other: Deep brain stimulation
  • Active Comparator: Deep Brain Stimulation
    Stimulator setting is ON
    Intervention: Other: Deep brain stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
60 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01094145
UK-09157
Yes
Jens Kuhn, University of Cologne
University of Cologne
Not Provided
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
University of Cologne
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP