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

October 12, 2017 updated by: Centre Hospitalier Universitaire de Besancon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besancon, France, 25000
        • Recruiting
        • CHU Besancon - Clinical Psychiatric Department
        • Principal Investigator:
          • Pierre Vandel, MD PhD
        • Sub-Investigator:
          • Eloi Magnin, MD PhD
      • Dijon, France
        • Not yet recruiting
        • Hopital Universitaire Dijon
        • Contact:
          • Bernard Bonnin, MD PhD
        • Principal Investigator:
          • Bernard Bonnin, MD PhD
        • Sub-Investigator:
          • Trojak Benoît, MD PhD
      • Paris, France
        • Recruiting
        • Assistance Publique - Hopitaux Paris
        • Contact:
        • Contact:
          • Hélène Francisque
        • Principal Investigator:
          • Claire Paquet, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: anodal tDCS on left DLPFC (F3)
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.
Device: transcranial Direct Current Stimulation (tDCS)
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.
Other Names:
  • EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)
SHAM_COMPARATOR: sham tDCS on left DLPFC (F3)
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.
Device: transcranial Direct Current Stimulation (tDCS)
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.
Other Names:
  • EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline cognitive functions at 3 weeks
Time Frame: baseline, day 5 and 3 weeks post-tDCS
neuropsychological assessments include Rapid battery tests (Bereay et al., 2015)
baseline, day 5 and 3 weeks post-tDCS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

Assistance Publique - Hôpitaux de Paris
Centre Hospitalier Universitaire Dijon

Investigators

  • Principal Investigator: Claire Paquet, MD PhD, Assitance Publique - Hôpitaux Paris
  • Principal Investigator: Bernard Bonnin, MD PhD, Centre Hospitalier Universaitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 19, 2013

Primary Completion (ANTICIPATED)

January 31, 2018

Study Completion (ANTICIPATED)

July 31, 2018

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (ESTIMATE)

August 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • API/2011/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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