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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Cologne.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT01094145
First received: March 25, 2010
Last updated: April 8, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention
Alzheimer Disease
 Other: Deep brain stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation of the Nucleus Basalis Meynert to Treat Cognitive Deficits in Light to Moderate Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • cognitive improvement [ Time Frame: one- year ] [ Designated as safety issue: No ]
    improving cognitive outcome parameters assessed by a series of standardized neuropsychological tests


Secondary Outcome Measures:
  • determination of the optimal stimulation parameter [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094145

Contacts
Contact: Volker Sturm, MD ++49221-478-4580 volker.sturm@uk-koeln.de
Contact: Jens Kuhn, MD ++49221-478-4005 jens.kuhn@uk-koeln.de

Locations
Germany
Uni-Klinik Köln AöR Recruiting
Cologne, North Rhine Westphalia, Germany, 50924
Contact: Jens Kuhn, MD     ++49221-478-4005     jens.kuhn@uk-koeln.de    
Contact: Volker Sturm, MD     ++49221-4784580     volker.sturm@uk-koeln.de    
Principal Investigator: Jens Kuhn, MD            
Principal Investigator: Volker Sturm, MD            
Sub-Investigator: Katja Hardenacke, Dipl.-Psych.            
Sub-Investigator: Doris Lenartz, MD            
Sub-Investigator: Wolfgang Huff, MD            
Sub-Investigator: Joachim Klosterkötter, Prof. Dr. med.            
Sub-Investigator: Christian P Bührle, Priv.-Doz. Dr. med.            
Sub-Investigator: Markus Ullsperger, Prof. Dr. med.            
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Prof. Dr. V. Sturm, Dr. J. Kuhn, University of Cologne
ClinicalTrials.gov Identifier: NCT01094145     History of Changes
Other Study ID Numbers: UK-09157
Study First Received: March 25, 2010
Last Updated: April 8, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Cologne:
(light to moderate)

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013