NCT03290274

Clinical Trial to Evaluate the Efficacy and Security of Deep Brain Stimulation in Alzheimer´s Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Approximately one million of Spaniards suffer from AlzhEimer´s Disease (AD) and this figure is expected to triple by 20150. The approved treatments modulate neurotransmission in general and are not specific or anatomically directed. In AD there is a dysfunction in cognitive and memory circuits. It has been shown that the deep brain stimulation (DBS) can specially modulate circuits in such a way that is modulable, and this approach is safe. The safety of this treatment and its biological effects are convincing enough to require further study of possible therapeutic effects of DBS in AD. The objectives are: To evaluate the security of DBS in AD (main objective). To study the influence of DBS in the progress of AD, to compare the effects of DBS on the brain metabolism neural connectivity and hubs using MEG, and to compare the effects between two different groups: fornix and Basal nucleus of Meynert (BNM). To achieve this, a prospective, double-blind comparison study between groups will be conducted, to evaluate the effects of DBS in 6 patients: group I (fornix) and group II ( BNM).

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	Deep brain stimulation (fornix)	Deep brain stimulation at fornix
DEVICE	Deep brain stimulation (Basal nucleus of Meynert)	Deep brain stimulation AT Basal nucleus of Meynert

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2017-09-21
• Last updated: 2017-09-21

Locations

1 site across 1 country: Spain