An interventional study of rTMS and rTMS treatment with intermittent Theta Burst (ITBS) in Autism Spectrum Disorder, Depression and Major Depressive Episode (MDE), sponsored by Hospital Center Guillaume Régnier. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Hospital Center Guillaume Régnier · Not applicable, Interventional, and Treatment
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.
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.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 25 is below the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Hospital Center Guillaume Régnier is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive 4 sessions of 10 minutes per day with a 50-minute interval between each session
Other: rTMS · Other: rTMS treatment with intermittent Theta Burst (ITBS)
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.
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.
Difference in MADRS (Montgomery-Asberg Depression Rating Scale ) score before versus after treatment.
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.
Time frame: From enrollment to the end of the data collecting process : 2 months.
Assessment of changes in irritability before versus after treatment
Irritability is assessed with the Angst scale. A global score of 10 or more indicates irritability.
Time frame: from enrolment to one month after the end of the rTMS treatment
assessment of changes in attention functions
Attentional functions are assessed using two subtests of the TAP (Test of Attentional Performance): * sustained attention : The test measures the ability to maintain attention over the long term with a high density of target stimuli. * Split Attention : The test explores the Ability to focus attention on two tasks simultaneously.
Time frame: From enrolment to one week then 1 month after the end of the rTMS treatment
Evolution of any side effects
Assessment of side effects of rTMS using the UKU scale
Time frame: During the treatment, at each stimulation time
Assement of change in repetitive behaviors before versus after treatment
BPI-1 (Behavior Problems Inventory) is an informant-based behaviour rating instrument that was designed to assess maladaptive behaviours in individuals with ASD. Its items fall into one of three sub-scales: Self-injurious Behavior (14 items), Stereotyped Behavior (24 items), and Aggressive/Destructive Behavior (11 items). Each item is rated on a frequency scale (0 = never to 4 = hourly), and a severity scale (0 = no problem to 3 = severe problem).
Time frame: 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
psychomotor decline is assessed with the depressive decline scale (ERD).This tool contains 14 items that describe the motor, verbal, ideational, hedonic, and cognitive behavior of depressed individuals. Each item is rated from 0 to 4 ( 1 expressing doubt about the pathological nature of the observed phenomenon).
Time frame: 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
Depression is assessed with the Patient Health Questionnaire - 9 items (PHQ-9) This is a brief tool used to assess and measure the severity of depression. Items are rated on a scale from 0 to 3. The maximum score is 27 (major depression)
Time frame: From enrolment to one week then one month after the end of the rTMS treatment
Assessment of changes in executive functions before versus after rTMS treatment
The TMT (Trial Making Test) measures attention, visual screening ability, and processing speed. The Trail Making Test is scored by how long it takes to complete the test
Time frame: From enrolment and 1 month after the end of rTMS treatment
Assessment of changes in executive functions before versus after rTMS treatment
The Stroop test measures recognition reaction times to color stimuli, evaluating psychomotor speed and cognitive flexibility.
Time frame: From enrolment and 1 month after the end of rTMS treatment
Assessment of changes in executive functions before versus after rTMS treatment
The GO/NO GO task measures the ability to inhibit and the control of impulses
Time frame: From enrolment and 1 month after the end of rTMS treatment
Plan to share: No — Data about study protocol and clinical information will be available on request from other researchers.
Started Dec 2024 (actual). Primary completion is estimated for Feb 2026, 14 months after the start.
Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 14 months is below that.
Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
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Hospital Center Guillaume Régnier