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Status unknownNCT03288363tDCS-ADUpdated Oct 22, 2021

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

An interventional study of tDCS in Alzheimer Disease, sponsored by Benjamin CALVET. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-22.

Sponsored by Benjamin CALVET · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Alzheimer Disease

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Keywords

  • tDCS
  • cognition
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DevicetDCS

    20 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus DC-Stimulator Plus (Neuroconn)

    Also known as: transcranial direct current stimulation

05

What researchers measure

Primary outcomes

  1. 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

    difference of ADAS-Cog psychometric scale score between sham and stimulation groups

    Time frame: 3 months

06

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier Esquirol
    Limoges, 87025, France
    • Murielle Girard · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03288363
Lead sponsor
Benjamin CALVET
Responsible party
Benjamin CALVET (principal investigator, Centre Hospitalier Esquirol) — Sponsor-investigator
First posted
Sep 20, 2017
Start date
Jun 6, 2017
Primary completion
Jun 6, 2024 (estimated)
Completion
Dec 6, 2024 (estimated)
Last update
Oct 22, 2021

Study contacts

Murielle Girard, PhD
Contact
murielle.girard@ch-esquirol-limoges.fr
0033555431028
Benjamin Calvet, MD, PhD
principal investigator · Centre Hospitalier Esquirol

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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