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

NCT ID: NCT03290274

Last Updated: 2017-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-12-01

Brief Summary

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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).

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Deep brain stimulation (fornix)

Deep brain stimulation at fornix area

Group Type EXPERIMENTAL

Deep brain stimulation (fornix)

Intervention Type DEVICE

Deep brain stimulation at fornix

Deep brain stimulation (Basal nucleus of Meynert)

Deep brain stimulation at Basal nucleus of Meynert

Group Type EXPERIMENTAL

Deep brain stimulation (Basal nucleus of Meynert)

Intervention Type DEVICE

Deep brain stimulation AT Basal nucleus of Meynert

Interventions

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Deep brain stimulation (fornix)

Deep brain stimulation at fornix

Intervention Type DEVICE

Deep brain stimulation (Basal nucleus of Meynert)

Deep brain stimulation AT Basal nucleus of Meynert

Intervention Type DEVICE

Eligibility Criteria

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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…)
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital San Carlos, Madrid

OTHER

Sponsor Role lead

Responsible Party

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Juan Antonio Barcia Albacar

Head of Neurosurgery Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aurora Viloria, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico San Carlos

Locations

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Hospital Clinico San Carlos

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Aurora Viloria, MD

Role: CONTACT

[email protected]
+34913003306

Facility Contacts

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Aurora Viloria, MD

Role: primary

[email protected]
+34913003306

References

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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.

Reference Type DERIVED
PMID: 35431895 (View on PubMed)

Other Identifiers

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ECP-EA

Identifier Type: -

Identifier Source: org_study_id