Transcranial Direct Current Stimulation and Early Alzheimer's Disease (tDCS-AD) (tDCS-AD)

October 21, 2021 updated by: Benjamin CALVET

Effects at 12 Weeks of Transcranial Direct Current Stimulation on the Cognitions of People Presenting Early Alzheimer's Disease (tDCS-AD)

TDCS is a rapidly expanding technique, used to treat cognitive difficulties associated with many pathologies (Parkinson's disease, rehabilitation after head trauma, etc.), but which remains of the field of research.

Its use remains very experimental, and concerns the exploration of cognitions, in healthy and diseased subjects. There are not many studies on the elderly subject with Alzheimer's disease, nor do they document the medium- and long-term effect (more than one month), nor the effect on geriatric parameters such as Fragility indices and the risk of falls, especially at home. These characteristics are decisive because they define the level of autonomy.

The investigators therefore wish to study the effect of a 2-week treatment with tDCS (tDCS active) versus placebo (2-week tDCS group) for a three-month period.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Alzheimer's disease and related syndromes have become a major public health priority issue in France. Pharmacological treatments are ineffective and symptomatic, and only delay the progression of the disease.

The management of Alzheimer's disease involves the development of multi-domain prevention programs, including physical activity and neurostimulation by cognitive stimulation. They aim to delay the appearance of fragility defined according to Fried by difficulties in walking, weight loss, fatigue, lack of wrist strength and sedentary lifestyle.

Transcranial direct current stimulation (tDCS) is a stimulation technique using a low intensity DC electric current that acts by modulating neuronal excitability at the cerebral level.

According to recent data, by its action on the cerebral cortex, this simple and non-invasive stimulation technique could prevent the effects of pathological aging, and reduce the cognitive difficulties of the elderly concerning episodic memory, attention and executive functions. These difficulties are also factors related to the risk of the elderly falling (defined by the slowness of walking speed, reduced monopodal support time and the existence of a falling antecedent).

TDCS is a rapidly expanding technique, used to treat cognitive difficulties associated with many pathologies (Parkinson's disease, rehabilitation after head trauma, etc.), but which remains of the field of research.

Its use remains very experimental, and concerns the exploration of cognitions, in healthy and diseased subjects. There are not many studies on the elderly subject with Alzheimer's disease, nor do they document the medium- and long-term effect (more than one month), nor the effect on geriatric parameters such as Fragility indices and the risk of falls, especially at home. These characteristics are decisive because they define the level of autonomy.

The investigators therefore wish to study the effect of a 2-week treatment with tDCS (tDCS active) versus placebo (2-week tDCS group) on these criteria. This effect may stop or curb cognitive decline.

Study Type

Interventional

Enrollment (Anticipated)

80

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 Locations

  • France
      • Limoges, France, 87025
        • Recruiting
        • Centre Hospitalier Esquirol
        • Contact:
          • Murielle Girard

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A man or woman with probable Alzheimer's disease diagnosed according to the criteria of the National Institute of Neurological and Communicative Disorders Association (NINCDS-ADRDA)
  • Age ≥ 60 years
  • Mini Mental State Examination ≥ 18
  • Clinical Demential Rating ≤ 1
  • Availability of a caregiver for assessments
  • Patient care in Day Hospital
  • Informed consent of the subject or his legal representative
  • General somatic state consistent with study procedures

Exclusion Criteria:

  • Presentation of contraindications to tDCS (presence of intracranial metal implants, intracranial hypertension, comitial risk).
  • In case of anticholinesterase treatment: taken for at least 6 months and at a non stable dose for 4 months.
  • Taking an antagonist treatment of NMDA receptors (anodic and cathodic) which cancels post-stimulation effects (memantine).
  • Other types of dementia or neurological disorder according to Diagnostic and Statistical Manual of Mental Disorders-5 (dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease, Huntington's disease, stroke, major head trauma, cerebral neoplasia, systemic disease ...) , Which can lead to alterations in the functioning of the central nervous system.
  • psychiatric disorder according to DSM-5, other than Alzheimer's disease including amnestic disorders, delirium, schizophrenia or schizoaffective disorder, bipolar disorder, major depressive episode in progress, psychosis, panic attacks, post traumatic stress disorder And / or cognitive impairment not otherwise specified.
  • Any other disorder for which treatment is given priority over the treatment of Alzheimer's disease or is likely to interfere with the study treatment or impairing adherence.
  • Accommodation in an institution (EHPAD, EHPA) or request in progress.
  • Participation in other biomedical research during the study that may interfere with the objectives of the study.
  • Person who had a recent change (<1 month) of psychotropic treatment.
  • Person with a place of residence more than 80 km away.
  • Person without health insurance.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS
20 sessions tDCS (DC-Stimulator Plus -Neuroconn) during 2 Weeks on temporal cortex - each session : 30 minutes - 2 mA - 2 sessions per day - evaluation at 12 weeks post-treatment
Device: tDCS
20 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus DC-Stimulator Plus (Neuroconn)
Other Names:
  • transcranial direct current stimulation
Sham Comparator: sham stimulation
the same parameters of stimulation as with real current stimulation (time, parameters to be seen on the apparatus screen) 20 sessions during 2 Weeks on temporal cortex - each session : 30 minutes - 2 sessions per day.
Device: tDCS
20 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus DC-Stimulator Plus (Neuroconn)
Other Names:
  • transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing between the active tDCS group with the placebo tDCS group, the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) score, 12 weeks after the start of the course, in subjects with early Alzheimer's disease
Time Frame: 3 months
difference of ADAS-Cog psychometric scale score between sham and stimulation groups
3 months

Collaborators and Investigators

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

Sponsor

Benjamin CALVET

Investigators

  • Principal Investigator: Benjamin Calvet, MD, PhD, Centre Hospitalier Esquirol

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)

June 6, 2017

Primary Completion (Anticipated)

June 6, 2024

Study Completion (Anticipated)

December 6, 2024

Study Registration Dates

First Submitted

September 17, 2017

First Submitted That Met QC Criteria

September 17, 2017

First Posted (Actual)

September 20, 2017

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A01527-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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