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

NCT02873546 | Unknown

• 1 other identifier: API/2011/24
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• change from baseline cognitive functions at 3 weeks

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

  baseline, day 5 and 3 weeks post-tDCS

Study Arms (2)

anodal tDCS on left DLPFC (F3)

ACTIVE COMPARATOR

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)

sham tDCS on left DLPFC (F3)

SHAM COMPARATOR

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)

Interventions

transcranial Direct Current Stimulation (tDCS) 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.

Also known as: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)

anodal tDCS on left DLPFC (F3); sham tDCS on left DLPFC (F3)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Centre Hospitalier Universitaire Dijon: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (3)

CHU Besancon - Clinical Psychiatric Department

Besançon, 25000, France

RECRUITING

Hopital Universitaire Dijon

Dijon, France

NOT YET RECRUITING

Assistance Publique - Hôpitaux Paris

Paris, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 26212200 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Pick Disease of the Brain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Claire Paquet, MD PhD

  Assitance Publique - Hôpitaux Paris

  PRINCIPAL INVESTIGATOR

• Bernard Bonnin, MD PhD

  Centre Hospitalier Universaitaire Dijon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Vandel, MD PhD

CONTACT

+33381219007; pierre.vandel@univ-fcomte.fr

Magali Nicolier, PhD

CONTACT

+33381219007; mnicolier@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 19, 2016
• Study Start: July 19, 2013
• Primary Completion: January 31, 2018
• Study Completion: July 31, 2018
• Last Updated: October 13, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)