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

NCT ID: NCT02873546

Last Updated: 2017-10-13

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-19

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease Progressive Primary Aphasia Early or Mild State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

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.

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.

Group Type SHAM_COMPARATOR

transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Paquet, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assitance Publique - Hôpitaux Paris

Bernard Bonnin, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universaitaire Dijon

Locations

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CHU Besancon - Clinical Psychiatric Department

Besançon, , France

Site Status RECRUITING

Hopital Universitaire Dijon

Dijon, , France

Site Status NOT_YET_RECRUITING

Assistance Publique - Hôpitaux Paris

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre Vandel, MD PhD

Role: CONTACT

Phone: +33381219007

Email: [email protected]

Magali Nicolier, PhD

Role: CONTACT

Phone: +33381219007

Email: [email protected]

Facility Contacts

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Magali Nicolier, PhD

Role: primary

Bernard Bonnin, MD PhD

Role: primary

Hélène Francisque

Role: primary

Hélène Francisque

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 26212200 (View on PubMed)

Other Identifiers

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API/2011/24

Identifier Type: -

Identifier Source: org_study_id