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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep brain stimulation (fornix) | Experimental | Deep brain stimulation at fornix area |
|
| Deep brain stimulation (Basal nucleus of Meynert) | Experimental | Deep brain stimulation at Basal nucleus of Meynert |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation (fornix) | Device | Deep brain stimulation at fornix |
|
| Measure | Description | Time Frame |
|---|---|---|
| Security | Determinate number of adverse event in each group such as infections, hospitalization, epilepsia, bleeding or hemiparesis | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurora Viloria, MD | Contact | +34913003306 | mariaaurora.viloria@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Aurora Viloria, MD | Hospital Clinico San Carlos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico San Carlos | Recruiting | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35431895 | Derived | Barcia JA, Viloria MA, Yubero R, Sanchez-Sanchez-Rojas L, Lopez A, Strange BA, Cabrera M, Canuet L, Gil P, Nombela C. Directional DBS of the Fornix in Alzheimer's Disease Achieves Long-Term Benefits: A Case Report. Front Aging Neurosci. 2022 Apr 1;14:809972. doi: 10.3389/fnagi.2022.809972. eCollection 2022. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Deep brain stimulation (Basal nucleus of Meynert) | Device | Deep brain stimulation AT Basal nucleus of Meynert |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |