Feasibility and Efficacy of rTMS in Depression in Individuals With Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Difference in MADRS (Montgomery-Asberg Depression Rating Scale ) score before versus after treatment.
研究概览
简要总结
Depression is a common complication of Autism Spectrum Disorder (ASD): it is four times more prevalent in people with ASD than in the general population.
However, treating depression in people with ASD is complicated by the lack of guidelines. Antidepressants appear to be less effective and less well tolerated than in the general population.
rTMS (repetitive transcranial magnetic stimulation) is a technique that stimulates the brain in a painless and non-invasive way. This technique is well tolerated and has very few side effects (headaches, fatigue). It is now used routinely in clinical practice to treat resistant depression, with satisfactory results.
A few studies using rTMS in depression in people with ASD have shown encouraging results and avenues for improvement.
It could therefore be interesting to conduct a therapeutic study with rTMS on depression in people with ASD, following the avenues for improvement proposed by previous studies.
The main objective is to evaluate the effectiveness of rTMS in depressed patients with ASD by looking at changes in mood before and after treatment. The investigator will also look at the effects on executive and attentional functions and repetitive behaviors, as well as treatment tolerance.
详细描述
Depression is a common comorbidity of autism spectrum disorder (ASD). Its prevalence is four times higher than in the neurotypical population, with specific symptoms, particularly irritability. However, the management of major depressive episodes (MDEs) in patients with ASD is complicated by the lack of specific recommendations for depression in ASD, while the effectiveness of pharmacological treatments is limited in this context.
rTMS (repetitive transcranial magnetic stimulation) is a technique that stimulates brain tissue in a non-invasive and painless manner, with good tolerance and few side effects. In the neurotypical population, it is used routinely in clinical practice to treat resistant EDMs, with satisfactory results.
To date, there are few studies on the treatment of depression in patients with ASD using TMS. Although these studies have certain limitations, they have shown encouraging results. These two studies are open-label studies involving fewer than 20 patients, but they show a significant improvement in depression scales before and after TMS treatment. The stimulation parameters (stimulation target: left dorsolateral prefrontal cortex, 15 to 30 sessions at a rate of one session per day, stimulation frequency of 10Hz for the first study and 50Hz in theta burst for the second) are those used in studies on depression in neurotypical depressed patients. In addition to the small sample size, these open-label studies have limitations in terms of parameter potentiation (target localisation, number of pulses per session and per day). It may therefore be worthwhile conducting a preliminary study to assess the feasibility and efficacy of rTMS in depressed ASD patients using an innovative accelerated, high-dose intermittent theta burst stimulation protocol with precise targeting of the stimulation site using neuronavigation and a detailed assessment of clinical depression in ASD, including irritability. Furthermore, an improvement in cognitive functions has been observed in neurotypical depressed patients receiving rTMS at the dorsolateral prefrontal cortex. It would therefore be interesting to study the impact of rTMS on executive and attentional functions using these innovative stimulation parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a diagnosis of ASD validated by a psychiatrist or line 2
- •Patient aged 18 to 65...
- •Patients suffering from EDM (MADRS greater than 20)
- •No change in treatment in the month prior to inclusion
- •Patients affiliated with or entitled to social security
- •Patients who have received informed information about the study and have signed a consent form to participate in the study
排除标准
- •Patients with psychiatric comorbidity (decompensated manic state, schizophrenic disorder)
- •Pregnancy at the time of inclusion
- •Patients with contraindications to rTMS and MRI (history of epilepsy, neurological stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid shunt, metal fragments in the eyes, claustrophobia)
- •Adults under legal protection (legal guardianship, curatorship, trusteeship), persons deprived of their liberty, persons hospitalised under compulsion (SDT, SDRE).
研究组 & 干预措施
ASD patients with depression
Patients receive 4 sessions of 10 minutes per day with a 50-minute interval between each session
干预措施: rTMS (Other)
ASD patients with depression
Patients receive 4 sessions of 10 minutes per day with a 50-minute interval between each session
干预措施: rTMS treatment with intermittent Theta Burst (ITBS) (Other)
结局指标
主要结局
Difference in MADRS (Montgomery-Asberg Depression Rating Scale ) score before versus after treatment.
时间窗: From enrollment to the end of the data collecting process : 2 months.
Upon inclusion, patients are assessed for mood using the MADRS.(inclusion criterion: MADRS\>20). The primary endpoint is the change in MADRS score one week after the end of treatment and one month after the end of treatment. score ranges from 0 to 60. The higher the score, the more severe the disorder is.
次要结局
- Assessment of changes in executive functions before versus after rTMS treatment(From enrolment and 1 month after the end of rTMS treatment)
- Assessment of changes in irritability before versus after treatment(from enrolment to one month after the end of the rTMS treatment)
- assessment of changes in attention functions(From enrolment to one week then 1 month after the end of the rTMS treatment)
- Evolution of any side effects(During the treatment, at each stimulation time)
- Assement of change in repetitive behaviors before versus after treatment(from enrolment and 1 month after the end of rTMS treatment)
- assessment of changes in mood aspects in terms of psychomotor decline before versus after rTMS treatment(from enrolment to one week then one month after the end of the rTMS treatment)
- assessment of changes in mood aspects in terms of depression before versus after rTMS treatment(From enrolment to one week then one month after the end of the rTMS treatment)