Centre Hospitalier Guillaume Régnier
Rennes, 35000, France
Location status: Recruiting
Location contact
Cécilia NAUCZYCIEL
CONTACT
+332 99 68 29 63 ext. +33
Nathalie ALLETON
CONTACT
+332 22 51 41 21 ext. +33
NCT Number: NCT07258914
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Rennes, 35000, France
Location status: Recruiting
Cécilia NAUCZYCIEL
CONTACT
+332 99 68 29 63 ext. +33
Nathalie ALLETON
CONTACT
+332 22 51 41 21 ext. +33
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: from enrolment to one month after the end of the rTMS treatment
Irritability is assessed with the Angst scale. A global score of 10 or more indicates irritability.
Time frame: From enrolment to one week then 1 month after the end of the rTMS treatment
Attentional functions are assessed using two subtests of the TAP (Test of Attentional Performance):
Time frame: During the treatment, at each stimulation time
Assessment of side effects of rTMS using the UKU scale
Time frame: from enrolment and 1 month after the end of rTMS 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 to one week then one month after the end of the 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
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 and 1 month after the end of 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
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
The GO/NO GO task measures the ability to inhibit and the control of impulses
Hospital Center Guillaume Régnier
Other
Feasibility and Efficacy of rTMS in Depression in Individuals With Autism Spectrum Disorder (ASD)
Acronym: DEPASS'R
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07722949
Anxiety, Anxiety Disorders
Faisalābad, Punjab Province, Pakistan
View Trial DetailsNCT03217110
Autism Spectrum Disorder, Basal Ganglia Diseases
Iowa City, Iowa, United States
View Trial DetailsNCT06060860
Anxiety, Anxiety Disorders
Chapel Hill, North Carolina, United States
View Trial DetailsNCT05698589
Autism Spectrum Disorder, Behavior
Bordeaux, France
View Trial Details