Ignite Creation Date:
2024-05-05 @ 9:26 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00888056
Status:
UNKNOWN
Last Update Posted:
2012-06-27
First Post:
2009-04-23
Brief Title:
Chronic Electrical Stimulation of HypothalamusFornix in Alzheimers Disease
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Effect of Deep Brain Stimulation of the Hypothalamus Fornix on Memory Impairment in Patients With Alzheimers Disease
Status:
UNKNOWN
Status Verified Date:
2009-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Alzheimers 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 downstabilize their symptoms which no other treatment can currently offer and to increase their quality of life
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 downstabilize their symptoms which no other treatment can currently offer and to increase their quality of life
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None