Transcranial Direct Current Stimulation (tDCS) and Anorexia Nervosa
NCT ID: NCT02734108
Last Updated: 2021-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2016-01-06
2018-05-02
Brief Summary
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Transcranial direct current stimulation (tDCS) is a neuromodulation technique that uses an electrical current of low intensity. It allows to modulate the corticospinal excitability: two electrodes, an anode (excitatory) and a cathode (inhibitory), are positioned on the skull according to the region which is desired to influence the operation.
Although tDCS was shown to no noticeable side effects, it is first necessary to assess the feasibility and safety of this technique in these physically frail patients. A recent pilot study suggests the acceptability, safety and efficacy of tDCS program in patients with anorexia nervosa.
Given these preliminary data and the extreme seriousness and vulnerability of patients with resistant anorexia, the investigators want to assess the risk / benefit ratio for the use of this technique in patients suffering from resistant anorexia nervosa. The current data are too preliminary to consider a randomized controlled trial, the investigators hope, initially, replicate the data from this pilot study in a second sample with a more rigorous and comprehensive assessment methodology .
Detailed Description
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20 sessions will be conducted twice a day respecting a period of four hours between sessions.
The tDCS sessions will start maximum 15 days after the inclusion visit.
Two intermediate control visits will be conducted. One after the first week of tDCS, the other immediately after the last session of tDCS.
The main assessment visit will be carried out one month (+/- 5 days) after the last session of tDCS. Finally a reminder visit will be performed 6 months (+/- 3 weeks) after the last session of tDCS to assess the stability over time of the potential effects observed.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Transcranial direct current stimulation
10 patients will be stimulated twice a day for two weeks or 20 sessions. 2 milli ampere stimulation will be applied for 25 min respecting a period of four hours between sessions.
Transcranial direct current stimulation
Anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex
Interventions
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Transcranial direct current stimulation
Anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex
Eligibility Criteria
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Inclusion Criteria
* Attest to the failure of at least one outpatient treatment conducted by a specialized team (Level 2/3) for the management of patients with eating disorders according to the criteria of French Association for the Development of Specialized Approaches of eating disorders and General Direction of the care
* Have an effective mean of contraception throughout the study
* Being able to understand the nature, purpose and methodology of the study
* Being affiliated to a social security scheme or being the beneficiary of such a scheme.
* Having signed the informed consent
Exclusion Criteria
* Present a body mass index lower than 13.5
* Present a history of seizures or epilepsy
* Presenting a head injury and / or brain pathology
* Presenting an unstabilized serious physical illness
* Present pregnancy (attested by a blood test Beta-HCG) or breastfeeding
* Present physical disease that may affect cognitive abilities and brain structures (eg HIV infection, multiple sclerosis, lupus, Parkinson's disease, epilepsy, dementia ...)
* Deprived of liberty subject (judicial or administrative decision)
* People protected by law
18 Years
50 Years
FEMALE
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Sébastien GUILLAUME, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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Hopital Lapeyronie
Montpellier, , France
Countries
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References
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Strumila R, Thiebaut S, Jaussent I, Seneque M, Attal J, Courtet P, Guillaume S. Safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of Anorexia Nervosa. The open-label STAR study. Brain Stimul. 2019 Sep-Oct;12(5):1325-1327. doi: 10.1016/j.brs.2019.06.017. Epub 2019 Jun 19. No abstract available.
Other Identifiers
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2015-A00872-47
Identifier Type: OTHER
Identifier Source: secondary_id
UF 9587
Identifier Type: -
Identifier Source: org_study_id