Trials / Completed
CompletedNCT01094145
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- Sponsor
- University of Cologne · Academic / Other
- Sex
- All
- Age
- 60 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Deep brain stimulation | DBS in the Nucleus basalis Meynert |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2013-01-01
- Completion
- 2013-01-01
- First posted
- 2010-03-26
- Last updated
- 2013-06-07
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01094145. Inclusion in this directory is not an endorsement.