NCT07258914

Feasibility and Efficacy of rTMS in Depression in Patients With Autism Spectrum Disorder (ASD)

Feasibility and Efficacy of rTMS in Depression in Individuals With Autism Spectrum Disorder (ASD)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Hospital Center Guillaume Régnier · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Autism Spectrum Disorder
• Depression
• Major Depressive Episode (MDE)

Interventions

Type	Name	Description
OTHER	rTMS	Patients receive 20 sessions of intermittent theta burst stimulation of the left CPFDL over 5 days (4 sessions of 10 minutes per day with a 50-minute interval between each session). The CPFDL is located using neuronavigation, which requires an MRI scan (without contrast agent injection) before the sessions.
OTHER	rTMS treatment with intermittent Theta Burst (ITBS)	rTMS (iTBS) treatment with stimulation of the left dorsolateral prefrontal cortex (DLPFC). Localization is performed using neuronavigation. There are four 10-minute sessions per day, with a 50-minute interval between each session.

Timeline

• Start date: 2024-12-19
• Primary completion: 2026-02-19
• Completion: 2026-02-19
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: France