Functional Electrical Stimulation for MDD

Официальное название

Functional Electrical Stimulation for Major Depressive Disorder: A Pilot Randomized Control Trial

Обзор

This study aims to determine whether Functional Electrical Stimulation (FES) of the facial muscles is a safe and effective treatment for major depressive disorder (MDD).

Подробное описание

A potential new treatment for Major Depressive Disorder (MDD) involves using a Functional Electrical Stimulation (FES) device to stimulate specific facial muscles. By targeting muscles related to smile patterns, FES has shown promise in improving emotional control and boosting mood. This project aims to address a critical need for innovative treatments for MDD, especially since 30% of MDD patients do not respond to traditional treatments.

This is a single-site clinical trial that is double-blind, randomized, and sham-controlled, involving 20 sessions of FES over four weeks. The trial will assess the effectiveness, safety, and tolerability of FES for individuals with mild-to-moderate major depressive episode (MDE) and a primary diagnosis of MDD.

Participants in the study will have a total of 26 visits: one screening and one baseline visit (both conducted by phone), followed by 20 on-site intervention visits over four weeks (one sessions per day). After the treatment, there will also be four follow-up visits over the phone to check how long the effects of the FES treatment last.

Вмешательства

• Устройство Functional Electrical Stimulation (FES)
  Once per day for the duration of 4 weeks. Total of 20 sessions (each session lasts 60 mins)

Первичные конечные точки

• Efficacy of FES: Change in Depression Severity [Срок оценки: 4 weeks of Intervention, 4 weeks of follow-up]
• Tolerability of FES [Срок оценки: 4 weeks of Intervention, 4 weeks of follow-up]
• FES safety [Срок оценки: 4 weeks of Intervention, 4 weeks of follow-up]

Вторичные конечные точки (5)

• Change in Anxiety Symptoms [Срок оценки: 4 weeks of Intervention, 4 weeks of follow-up]
• Change in Well-Being [Срок оценки: 4 weeks of Intervention, 4 weeks of follow-up]
• Change in Sleep Quality [Срок оценки: 4 weeks of Intervention, 4 weeks of follow-up]
• Response and Remission Rate [Срок оценки: 4 weeks of Intervention, 4 weeks of follow-up]
• Changes in Facial Expressivity [Срок оценки: 4 weeks of Intervention]

Критерии участия

Критерии включения

Patients will be included if they:

• Meet the DSM-5 criteria for unipolar MDD with a current MDE without psychotic features, with ≤ 2 failed treatment trials (non-treatment-resistant depression), validated by MINI done by a trained research assistant.
• Have no change in the medication regimen or other forms of treatments (e.g., psychotherapy) for at least 4 weeks (28 days) prior to beginning the study, and have no plan to change them during the 20-session treatment period (14 days), and the 4-week post-treatment observation period. This will be established through self-report, in combination with the ATHF filled out by the participant.
• Have an MDD diagnosis as confirmed by the MADRS score of ≥7.
• Age group between 18 and 70 years of age

Критерии исключения

Patients will be excluded if they:

• History of epilepsy or seizures.
• Damage or dysfunction of facial nerves.
• Metallic orthopedic implants in the mouth (e.g., plates or screws).
• Current fibromyalgia or currently receiving or have received rTMS within the last 28 days before the screening.
• History of treatment-resistant depression (TRD) with history of ECT, Magnetic Seizure Therapy, Intravenous Ketamine use in the past or failure of >2 antidepressant treatments of adequate duration and dose during the current episode.
• Past or current symptoms of mania, hypomania, mixed episodes, psychotic disorders, obsessive-compulsive disorder, post-traumatic stress disorder, active substance abuse or dependence (excluding nicotine and caffeine), neurodegenerative disease, or dementia. This will be confirmed on the MINI (77) administered by a trained research assistant.
• Current suicidal intent or plan as demonstrated by a score of ≥4 on MADRS item 10.
• Unable to understand instructions in English.
• Unable to produce "Duchenne marker" expression with FES, secondary to any type of neurological condition or previous botulinum toxin treatments of facial muscles.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07629050 · 24-155 · WI4 179978

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗