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

NCT07258914 | Recruiting

• 2 other identifiers: RC24_01_CN_DEPASS'R2024-A01125-42
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Autism Spectrum Disorder; Depression; Major Depressive Episode (MDE); Transcranial Magnetic Stimulation; Repetitive Transcranial Magnectic Stimulation (rTMS); rTMS; Neurodivergent; executive and attentional function

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of the data collecting process : 2 months.

Secondary Outcomes (9)

• 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

Study Arms (1)

ASD patients with depression

EXPERIMENTAL

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)

Interventions

rTMS OTHER

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.

ASD patients with depression

rTMS treatment with intermittent Theta Burst (ITBS) OTHER

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.

ASD patients with depression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• Patients with psychiatric comorbidity (decompensated manic state, schizophrenic disorder)
• 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).

Sponsors & Collaborators

• Hospital Center Guillaume Régnier: lead

Study Sites (1)

Centre Hospitalier Guillaume Régnier

Rennes, 35000, France

RECRUITING

Related Publications (5)

• Smith JR, DiSalvo M, Green A, Ceranoglu TA, Anteraper SA, Croarkin P, Joshi G. Treatment Response of Transcranial Magnetic Stimulation in Intellectually Capable Youth and Young Adults with Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Neuropsychol Rev. 2023 Dec;33(4):834-855. doi: 10.1007/s11065-022-09564-1. Epub 2022 Sep 26.

  PMID: 36161554 BACKGROUND

• Tong J, Zhang J, Jin Y, Liu W, Wang H, Huang Y, Shi D, Zhu M, Zhu N, Zhang T, Sun X. Impact of Repetitive Transcranial Magnetic Stimulation (rTMS) on Theory of Mind and Executive Function in Major Depressive Disorder and Its Correlation with Brain-Derived Neurotrophic Factor (BDNF): A Randomized, Double-Blind, Sham-Controlled Trial. Brain Sci. 2021 Jun 9;11(6):765. doi: 10.3390/brainsci11060765.

  PMID: 34207545 BACKGROUND

• Noda Y, Fujii K, Mimura Y, Taniguchi K, Nakajima S, Kitahata R. A Case Series of Intermittent Theta Burst Stimulation Treatment for Depressive Symptoms in Individuals with Autistic Spectrum Disorder: Real World TMS Study in the Tokyo Metropolitan Area. J Pers Med. 2023 Jan 11;13(1):145. doi: 10.3390/jpm13010145.

  PMID: 36675806 BACKGROUND

• Gwynette MF, Lowe DW, Henneberry EA, Sahlem GL, Wiley MG, Alsarraf H, Russo SB, Joseph JE, Summers PM, Lohnes L, George MS. Treatment of Adults with Autism and Major Depressive Disorder Using Transcranial Magnetic Stimulation: An Open Label Pilot Study. Autism Res. 2020 Mar;13(3):346-351. doi: 10.1002/aur.2266. Epub 2020 Jan 15.

  PMID: 31944611 BACKGROUND

• Hudson CC, Hall L, Harkness KL. Prevalence of Depressive Disorders in Individuals with Autism Spectrum Disorder: a Meta-Analysis. J Abnorm Child Psychol. 2019 Jan;47(1):165-175. doi: 10.1007/s10802-018-0402-1.

  PMID: 29497980 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Depression

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Cécilia NAUCZYCIEL, Doctor

  Centre Hospitalier Guillaume Régnier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: December 2, 2025
• Study Start: December 19, 2024
• Primary Completion: February 19, 2026
• Study Completion: February 19, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)