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

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ClinicalTrials.gov Identifier: NCT02873546
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : October 13, 2017
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Dijon
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Progressive Primary Aphasia Early or Mild State Device: transcranial Direct Current Stimulation (tDCS) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 19, 2013
Estimated Primary Completion Date : January 31, 2018
Estimated Study Completion Date : July 31, 2018


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 Name: 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 Name: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Germany)




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873546


Contacts
Contact: Pierre Vandel, MD PhD +33381219007 pierre.vandel@univ-fcomte.fr
Contact: Magali Nicolier, PhD +33381219007 mnicolier@chu-besancon.fr

Locations
France
CHU Besancon - Clinical Psychiatric Department Recruiting
Besancon, France, 25000
Contact: Magali Nicolier, PhD    +33381219007    mnicolier@chu-besancon.fr   
Principal Investigator: Pierre Vandel, MD PhD         
Sub-Investigator: Eloi Magnin, MD PhD         
Hopital Universitaire Dijon Not yet recruiting
Dijon, France
Contact: Bernard Bonnin, MD PhD         
Principal Investigator: Bernard Bonnin, MD PhD         
Sub-Investigator: Trojak Benoît, MD PhD         
Assistance Publique - Hôpitaux Paris Recruiting
Paris, France
Contact: Hélène Francisque    +33140054390    helene.francisque@gmail.com   
Contact: Hélène Francisque         
Principal Investigator: Claire Paquet, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Universitaire Dijon
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Claire Paquet, MD PhD Assitance Publique - Hôpitaux Paris
Principal Investigator: Bernard Bonnin, MD PhD Centre Hospitalier Universaitaire Dijon

Publications:
Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02873546     History of Changes
Other Study ID Numbers: API/2011/24
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Alzheimer Disease
Aphasia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases