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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

August 11, 2016
August 19, 2016
October 13, 2017
July 19, 2013
January 31, 2018   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT02873546 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
tDCS Effect on Cognitive Functions From Patients With Alzheimer's Disease or Progressive Primary Aphasia
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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Alzheimer's Disease
  • Progressive Primary Aphasia
  • Early or Mild State
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)
  • 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.
    Intervention: Device: transcranial Direct Current Stimulation (tDCS)
  • 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.
    Intervention: Device: transcranial Direct Current Stimulation (tDCS)
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-Comté: 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
52
Same as current
July 31, 2018
January 31, 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
60 Years and older   (Adult, Older Adult)
No
Contact: Pierre Vandel, MD PhD +33381219007 pierre.vandel@univ-fcomte.fr
Contact: Magali Nicolier, PhD +33381219007 mnicolier@chu-besancon.fr
France
 
 
NCT02873546
API/2011/24
No
Not Provided
Plan to Share IPD: No
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Universitaire de Besancon
  • Centre Hospitalier Universitaire Dijon
  • Assistance Publique - Hôpitaux de Paris
Principal Investigator: Claire Paquet, MD PhD Assitance Publique - Hôpitaux Paris
Principal Investigator: Bernard Bonnin, MD PhD Centre Hospitalier Universaitaire Dijon
Centre Hospitalier Universitaire de Besancon
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP