Deep Brain Stimulation (DBS) of the Nucleus Basalis Meyne... | NCT01094145

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

NCT01094145

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Jun 7, 2013Estimated

Enrollment

6Estimated

Phase

Not Applicable

Conditions

Alzheimer Disease

Interventions

Deep brain stimulation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Mar 25, 2010

First Submission Date that Met QC Criteria

Mar 25, 2010

First Posted Date

Mar 26, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2013

Last Update Posted Date

Jun 7, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Sham Comparator	Stimulator setting is OFF	Other: Deep brain stimulation
Deep Brain Stimulation	Active Comparator	Stimulator setting is ON	Other: Deep brain stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deep brain stimulation	Other	DBS in the Nucleus basalis Meynert	Deep Brain Stimulation Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
determination of the optimal stimulation parameter		one year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uni-Klinik Köln AöR		Cologne	North Rhine-Westphalia	50924	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26827109	Derived	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.

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D013514	Surgical Procedures, Operative