Feasibility and Efficacy of rTMS in Depression in Patients With Autism Spectrum Disorder (ASD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHospital Center Guillaume Régnier
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
rTMS
Other interventionPatients 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 treatment with intermittent Theta Burst (ITBS)
Other interventionrTMS (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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: ASD patients with depressionExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
From enrollment to the end of the data collecting process : 2 months.Secondary outcomes
1
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 treatment2
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 treatment3
Evolution of any side effects
Assessment of side effects of rTMS using the UKU scale
Time frame
During the treatment, at each stimulation time4
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 treatmentSponsors and contacts
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Source ClinicalTrials.gov