Back to results

tDCS Effect on Cognitive Functions From Patients With Alzheimer's Disease or Progressive Primary Aphasia (ALSTICO)

Primary Purpose

Alzheimer's Disease, Progressive Primary Aphasia, Early or Mild State

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

transcranial Direct Current Stimulation (tDCS)

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRADA) criteria (Alzheimer's patient) OR Gordo-Tempini criteria (PPA's patient)
CDR score ≤ 2
treatment by IAChE ≥ 3 months
MADRS score < 18
w/o severe progressive somatic pathology (especially tumor diseases)

Exclusion Criteria:

last neuropsychological assessment < 6 months
presence of a specific contraindication for tDCS (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker)

Sites / Locations

CHU Besancon - Clinical Psychiatric DepartmentRecruiting
Hopital Universitaire Dijon
Assistance Publique - Hôpitaux ParisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

anodal tDCS on left DLPFC (F3)

sham tDCS on left DLPFC (F3)

Arm Description

tDCS is a non-invasive neuromodulation method, which delivers a constant current of low intensity (1 mA) during 30 minutes for 10 sessions. Anode is placed on the scalp facing on left DLPFC (F3) and cathode between Fp2-F8 EEG-repair.

Sham tDCS differs from active tDCS by the interruption of stimulation after 15 sec and reactivation of the stimulation 15 sec before the end of the session (30 minutes - 10 sessions. Anode is placed on the scalp facing on left DLPFC (F3) and cathode between Fp2-F8 EEG-repair.

Outcomes

Primary Outcome Measures

change from baseline cognitive functions at 3 weeks

neuropsychological assessments include Rapid battery tests (Bereay et al., 2015)

Secondary Outcome Measures

Full Information

NCT ID

NCT02873546

First Posted

August 11, 2016

Last Updated

October 12, 2017

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

Centre Hospitalier Universitaire Dijon, Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT02873546

Brief Title

tDCS Effect on Cognitive Functions From Patients With Alzheimer's Disease or Progressive Primary Aphasia

Acronym

ALSTICO

Official Title

Evaluation de l'Effet de la tDCS Sur Les Fonctions Cognitives de Patients Souffrant de Maladie d'Alzheimer et Maladies apparentées au Stade léger

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 19, 2013 (Actual)

Primary Completion Date

January 31, 2018 (Anticipated)

Study Completion Date

July 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

Centre Hospitalier Universitaire Dijon, Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left Cortex DorsoLateral PreFrontal (CDLPF) of Alzheimer's or Primary Progressive Aphasia (PPA) patients compared to the application of a placebo tDCS (sham procedure) on cognitive functions, which are evaluated at short term (1 week post-treatment) and mild term (3 weeks post-treatment). After unblinding, patients who received placebo treatment could be received active tDCS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease, Progressive Primary Aphasia, Early or Mild State

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

anodal tDCS on left DLPFC (F3)

Arm Type

Active Comparator

Arm Description

Arm Title

sham tDCS on left DLPFC (F3)

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

transcranial Direct Current Stimulation (tDCS)

Other Intervention Name(s)

EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)

Intervention Description

After locating the stimulation areas, treatment will be delivered during 30-minute session. Treatment will be occur 2 session per day during 5 consecutive days. Subjects will be monitored during tDCS sessions for any side effects or adverse events.

Primary Outcome Measure Information:

Title

change from baseline cognitive functions at 3 weeks

Description

neuropsychological assessments include Rapid battery tests (Bereay et al., 2015)

Time Frame

baseline, day 5 and 3 weeks post-tDCS

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRADA) criteria (Alzheimer's patient) OR Gordo-Tempini criteria (PPA's patient) CDR score ≤ 2 treatment by IAChE ≥ 3 months MADRS score < 18 w/o severe progressive somatic pathology (especially tumor diseases) Exclusion Criteria: last neuropsychological assessment < 6 months presence of a specific contraindication for tDCS (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pierre Vandel, MD PhD

Phone

+33381219007

pierre.vandel@univ-fcomte.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Magali Nicolier, PhD

Phone

+33381219007

mnicolier@chu-besancon.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claire Paquet, MD PhD

Organizational Affiliation

Assitance Publique - Hôpitaux Paris

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bernard Bonnin, MD PhD

Organizational Affiliation

Centre Hospitalier Universaitaire Dijon

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Besancon - Clinical Psychiatric Department

City

Besancon

ZIP/Postal Code

25000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Magali Nicolier, PhD

Phone

+33381219007

mnicolier@chu-besancon.fr

First Name & Middle Initial & Last Name & Degree

Pierre Vandel, MD PhD

First Name & Middle Initial & Last Name & Degree

Eloi Magnin, MD PhD

Facility Name

Hopital Universitaire Dijon

City

Dijon

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bernard Bonnin, MD PhD

First Name & Middle Initial & Last Name & Degree

Bernard Bonnin, MD PhD

First Name & Middle Initial & Last Name & Degree

Trojak Benoît, MD PhD

Facility Name

Assistance Publique - Hôpitaux Paris

City

Paris

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hélène Francisque

Phone

+33140054390

helene.francisque@gmail.com

First Name & Middle Initial & Last Name & Degree

Hélène Francisque

First Name & Middle Initial & Last Name & Degree

Claire Paquet, MD PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26212200

Citation

Bereau M, Sylvestre G, Mauny F, Puyraveau M, Baudier F, Magnin E, Berger E, Vandel P, Galmiche J, Chopard G. [Assessment of 10 years of memory consultations in the Franche-Comte: Description and analysis of the RAPID regional database]. Rev Neurol (Paris). 2015 Sep;171(8-9):655-61. doi: 10.1016/j.neurol.2015.04.008. Epub 2015 Jul 23. French.

Results Reference

background

Learn more about this trial

tDCS Effect on Cognitive Functions From Patients With Alzheimer's Disease or Progressive Primary Aphasia

We'll reach out to this number within 24 hrs