Chronic Electrical Stimulation of Hypothalamus/Fornix in Alzheimer's Disease
|ClinicalTrials.gov Identifier: NCT00888056|
Recruitment Status : Unknown
Verified April 2009 by Centre Hospitalier Universitaire de Nice.
Recruitment status was: Recruiting
First Posted : April 24, 2009
Last Update Posted : June 27, 2012
Alzheimer's Disease (AD) is the most common cause of dementia for which no treatment has shown consistent efficacy to stop or slow down the disease. Recent report of enhancement of memory abilities by bilateral chronic deep brain stimulation (DBS) of the fornix in the hypothalamus suggests that neuromodulation of circuits involved in memory processes may have therapeutic implications in AD patients with memory decline.
The primary objectives of this prospective, non-controlled, pilot study are to evaluate the feasibility and safety of DBS in AD patients with mild cognitive and memory impairment, and to evaluate the efficacy of DBS to slow down or stabilize this decline. Five patients with AD (DSM IV) diagnosed less than two years, with mild cognitive decline (MMSE 20-24), and specific impairment of episodic memory will be included in a 2-year period. The evaluation criteria for feasibility will be the proportion of patients undergoing the procedure, chronic stimulation and evaluation process without adverse event (AE). Efficacy will be evaluated using numerous cognitive and memory testing. Changes in behavioral and mood scales, and changes in hypothalamic functions (clinical, biological and hormonal assessment) will evaluate safety and tolerance. Clinical, neuro-psychological, biological and imaging assessment will be performed 3 and one month before and 3, 6, 12 and 24 months after surgery. Bilateral electrodes (Medtronic 3389) will be implanted, by MR-guided frame-based stereotaxy, in the hypothalamic part of the fornix, and then connected to the generator (Kinetra, Medtronic). Chronic high-frequency stimulation will be delivered immediately after surgery.
The investigators expect to slow down, or to stabilize the spontaneous decline of MMSE and ADAS scores after 6, 12 and 24 months of stimulation. In case of efficacy, DBS might offer to AD patient the possibility to slow down/stabilize their symptoms, which no other treatment can currently offer, and to increase their quality of life.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Procedure: Bilateral chronic electrical stimulation of the hypothalamus/fornix||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Deep Brain Stimulation of the Hypothalamus/ Fornix on Memory Impairment in Patients With Alzheimer's Disease|
|Study Start Date :||June 2009|
Experimental: ARM A
Bilateral chronic electrical stimulation of the hypothalamus/fornix
Procedure: Bilateral chronic electrical stimulation of the hypothalamus/fornix
Clinical, neuro-psychological, biological and imaging assessment will be performed 3 and one month before and 3, 6, 12 and 24 months after surgery. Bilateral electrodes (Medtronic 3389) will be implanted, under local anesthesia, by MR-guided frame-based stereotaxy, in the hypothalamic part of the fornix, before its entry in the mamillary body (well defined on T2 weighted sequences). Intra-operative stimulation will be used to search adverse effects or acute effects. Electrodes will be connected to the generator (Kinetra, Medtronic) under general anesthesia. Chronic high-frequency stimulation will be delivered immediately after surgery.
- Evaluation criteria for feasibility will be the proportion of patients undergoing the procedure, chronic stimulation and evaluation process without adverse event. [ Time Frame: once time ]
- Efficacy will be evaluated using numerous cognitive and memory testing. Neuro-imaging changes after stimulation will be evaluate by morphological MRI and functional imaging (PET). Changes in behavioral and mood scales: evaluate safety [ Time Frame: M-3, D-7, D7, M3, M6, M12, M24 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888056
|Contact: Robert Philippe, PhDemail@example.com|
|Contact: Fontaine Denys, PhDfirstname.lastname@example.org|
|CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez||Recruiting|
|Nice, Alpes-Maritimes, France, 06001|
|Contact: ROBERT Philippe, PhD +33492037993 email@example.com|
|Contact: Fontaine Denys, PhD +33492038450 firstname.lastname@example.org|
|Principal Investigator: Robert Philippe, PhD|
|Principal Investigator: Fontaine Denys, PhD|
|Principal Investigator:||Fontaine Denys, PhD||CHU de Nice - Service de Neurochirurgie - Hôpital Pasteur - 30 av de la voie Romaine - 06 100 Nice|
|Principal Investigator:||ROBERT Philippe, PhD||CHU de Nice - CM2R - Hôpital de cimiez- 4 av reine Victoria 06001 Nice|