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Status unknownNCT03290274ECP-EAUpdated Sep 21, 2017

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

An interventional study of Deep brain stimulation (fornix) and Deep brain stimulation (Basal nucleus of Meynert) in Alzheimer Disease, sponsored by Hospital San Carlos, Madrid. Status unknown at 1 site in Spain. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-09-21.

Sponsored by Hospital San Carlos, Madrid · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Alzheimer Disease

Browse trials for

Keywords

  • Deep brain stimulation
  • Alzheimer´s Disease
  • Fornix
  • Basal nucleus of Meynert
03

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
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

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...)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    Deep brain stimulation (fornix)

    Deep brain stimulation at fornix area

    Device: Deep brain stimulation (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)

Interventions

  • DeviceDeep brain stimulation (fornix)

    Deep brain stimulation at fornix

  • DeviceDeep brain stimulation (Basal nucleus of Meynert)

    Deep brain stimulation AT Basal nucleus of Meynert

05

What researchers measure

Primary outcomes

  1. Security

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

    Time frame: 2 years

06

Study locations

1 of 1 sites recruiting
07

References and documents

Publications

  • 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. PubMed 35431895 ↗
08

Registry details

Key details

Study ID
NCT03290274
Lead sponsor
Hospital San Carlos, Madrid
Responsible party
Juan Antonio Barcia Albacar (Head of Neurosurgery Department, Hospital San Carlos, Madrid) — Principal investigator
First posted
Sep 21, 2017
Start date
Mar 1, 2017
Primary completion
Dec 1, 2019 (estimated)
Completion
Dec 1, 2019 (estimated)
Last update
Sep 21, 2017

Study contacts

Aurora Viloria, MD
Contact
mariaaurora.viloria@salud.madrid.org
+34913003306
Aurora Viloria, MD
principal investigator · Hospital Clinico San Carlos

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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