Distribution of study questionnaires
OtherThe questionnaires will be administered to patients at DO, D10, and M2. MADRS/RSES/EQ-5D-5L/BDI/CRQ
NCT Number: NCT07490379
Transcranial direct current stimulation (tDCS) is a neuromodulation method that modulates brain activity using low-intensity electrical current. Used in the treatment of depression, it is easily adaptable for both caregivers and patients, with good tolerance, under appropriate supervision.
Allowing patients to perform tDCS at home could address issues of access to care (distance from home, overall cost of care, lack of healthcare professionals, difficulty travelling for physical/psychological reasons, etc.). Studies on tDCS have highlighted the importance of regular clinical monitoring to ensure compliance and safety, which are essential factors for therapeutic efficacy.
The main objective of this study is to demonstrate the non-inferiority of tDCS performed at home versus in hospital in terms of effectiveness in reducing depressive symptoms at 6 weeks post-treatment in patients with moderate to severe depression.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Clinique Mirambeau, Anglet, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
o Failure of a maximum of 1 or 2 antidepressants taken successively or in combination for the current episode
Exclusion criteria
The questionnaires will be administered to patients at DO, D10, and M2. MADRS/RSES/EQ-5D-5L/BDI/CRQ
Protocol: 2 mA, 30 min, 10 working days (Monday to Friday), 2 sessions/day
During visits to the hospital, the nurse ensures that the patient knows how to use the device correctly.
The interviews will be conducted by telephone with patients participating in the study. The purpose of these interviews is to gather information for the qualitative aspect of the implementation.
Time frame: 2 months
The scale ranges from 0 to 60, with 60 representing the worst possible outcome.
Time frame: 2 Months
The scale ranges from 0 to 60, with 60 representing the worst possible outcome.
Time frame: 2 months
Time frame: 2 months
The scale ranges from 0 to 3, where 3 representing the worst possible outcome.
Time frame: 2 months
The scale ranges from 1 to 4, where 1 indicates "strongly disagree" and 4 indicates "strongly agree.
Time frame: 2 months
The scale ranges from 0 to 100, with 0 representing the worst possible outcome.
Time frame: 10 Days
The scale ranges from 0 to 10, with 10 representing the worst possible outcome.
Time frame: 2 months
Incremental cost-utility ratio (cost per QALY) at 2 months.
Time frame: 2 months
Time frame: 2 months
Qualitative analysis of data collected during semi-structured interviews with patients and their relatives regarding the suitability or unsuitability of the method of administering tDCS at home.
Time frame: 2 months
Time frame: 2 months
Ratio of the number of sessions completed to the number of sessions planned in each of the two groups. // Proportion of patients who discontinued the protocol before completion // Factors leading to deviations that resulted in the treatment being carried out over a longer period or in the tDCS stimulation treatment being discontinued.
Time frame: 2 months
Proportion of individuals included among those identified. Description of the reasons for excluding patients who were identified but not included. Frequency of inclusions.
Time frame: 2 months
Time frame: 2 months
Number of patients who completed the full course of tDCS treatment.
Time frame: 2 months
Time frame: 2 months
Contact information is provided by the study sponsor or research team.
Nantes University Hospital
Other
CAPUCINOO - Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients With Depressive Episodes: Non-inferiority Study, the Impact of Nursing Follow-up and Implementation of the Care Pathway
Acronym: CAPUCINOO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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