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

Sponsor
Hospital San Carlos, Madrid (Other)
Overall Status
Unknown status
CT.gov ID
NCT03290274
Collaborator
(none)
6
Enrollment
1
Location
2
Arms
33
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Device: Deep brain stimulation (fornix)
  • Device: Deep brain stimulation (Basal nucleus of Meynert)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Trial to Evaluate the Efficacy and Security of Deep Brain Stimulation in Alzheimer´s Disease
Actual Study Start Date :
Mar 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Deep brain stimulation (fornix)

Deep brain stimulation at fornix area

Device: Deep brain stimulation (fornix)
Deep brain stimulation at fornix
Experimental: Deep brain stimulation (Basal nucleus of Meynert)

Deep brain stimulation at Basal nucleus of Meynert

Device: Deep brain stimulation (Basal nucleus of Meynert)
Deep brain stimulation AT Basal nucleus of Meynert

Outcome Measures

Primary Outcome Measures

  1. Security [2 years]

    Determinate number of adverse event in each group such as infections, hospitalization, epilepsia, bleeding or hemiparesis

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age: Between 50-80 years old

  • Diagnosis criteria of Alzheimer disease (Dubois criteria) in the previous 2 years

  • Presence of tau, p-tau or Aβ in cerebrospinal fluid or positive amiloid-PET scan

  • Clinical dementia rating scale (CDR): 1

  • Use of cholinesterase inhibitors and/or memantine during one year at least, and worsening in neuropsychologic tests in spite of the treatment

  • Informed consent (patient and caregiver or legal representative)

Exclusion Criteria:

  • Brain structural disorders: primary or metastatic tumor, Hydrocephalus, stroke, brain abscess or cerebral malformation

  • Vascular dementia (NINCDS-AIREN criteria)

  • Neurodegenerative disease other than AD

  • Psychiatric disease

  • Epilepsy

  • Severe or unstable comorbidity (mellitus diabetes, high blood pressure…)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clinico San Carlos Madrid Spain

Sponsors and Collaborators

  • Hospital San Carlos, Madrid

Investigators

  • Principal Investigator: Aurora Viloria, MD, Hospital Clinico San Carlos

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Juan Antonio Barcia Albacar, Head of Neurosurgery Department, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:
NCT03290274
Other Study ID Numbers:
  • ECP-EA
First Posted:
Sep 21, 2017
Last Update Posted:
Sep 21, 2017
Last Verified:
Aug 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Juan Antonio Barcia Albacar, Head of Neurosurgery Department, Hospital San Carlos, Madrid
Deep brain stimulation
Alzheimer´s Disease
Fornix
Basal nucleus of Meynert
Additional relevant MeSH terms:
Alzheimer Disease

Study Results

No Results Posted as of Sep 21, 2017