Efficacy of Transcranial Magnetic Stimulation in children with Autism Spectrum Disorder

Active, not recruiting

• Conditions: Autistic disorder,

• Registration Number: CTRI/2019/02/017568
• Lead Sponsor: Vishal Sondhi

Brief Summary

BackgroundAutism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by varying degrees of maladaptive social interaction, poor language (verbal and nonverbal) and repetitive, restrictive behaviors. The incidence of ASD ranges between 1-2% worldwide. ASD is diagnosed clinically, based on the presence of key behavioral symptoms, but the underlying brain mechanisms causing these symptoms are unknown and there currently exists no cure. Most empirically supported treatments for the core symptoms of ASD focus on early intensive behavioral interventions (Reichow, 2012). Pharmacological treatments are at times effective in treating secondary and comorbid features of ASD, such as aggression or hyperactivity and attention deficit, or epilepsy (Hampson, Gholizadeh, & Pacey, 2012), but there is currently no pharmacotherapy shown to effectively treat the core symptoms of ASD.

Transcranial Magnetic Stimulation is a novel technique of non-invasive focal brain stimulation and creation of focal electric fields causing neuromodulation. Through a process of electromagnetic induction, it generates rapid pulse of electrical current that induces a rapidly fluctuating magnetic field, which in turn induces an electrical current in the underlying brain tissue (Barker, Jalinous, & Freeston, 1985; Wagner, Valero-Cabre, & Pascual-Leone, 2007). The potential of rTMS to induce a long-lasting modulation of cortical excitability and plasticity offers the possibility of its use for therapeutic purposes in neurological and psychological conditions thought to be a result of altered excitability or plasticity of specific neural circuits. There is growing interest in the possible role of TMS for diagnosing and treating ASD. There are preliminary data suggesting an improvement in both physiological indices and specific behavioral symptoms in children with ASD following rTMS. However, its definite efficacy, regime, dosage and duration are grey areas requiring standardization.

Hence, this randomized trial is being undertaken to study the hypothesis that among 6-16 years old children with ASD, once a week rTMS for twelve weeks will result in better improvement in behavioral symptoms as measured by Childhood Autism Rating Scale-2 (CARS-2) scores, at 12 weeks, as compared to sham therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-03
• Last Update Posted: 2021-06-27

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

(a) Indian Scale for Assessment of Autism Scores 70 or more (b) Either parent should be willing and capable of following instructions and maintaining activity log.

Exclusion Criteria

(a)History of seizure(s) in child or immediate (1st degree relative) family (b)Abnormal EEG (c)Secondary autism (as a co-morbidity of structural brain lesion, metabolic cause etc) (d) Children with concomitant chronic systemic illnesses that can interfere with administration of intervention (e)Children with any acute illness (f)Children with history of fainting spells (g) Children with metallic implants, pacemaker, VP shunt, Vagal Nerve Stimulator, Deep Brain Stimulator (h) Dysmorphism involving head (i)History of severe head injury (j)Progressive neurological illness (k)Children on medicines that decrease seizure threshold (eg.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare 6-16-year-old children and adolescents with Autism Spectrum Disorder (ASD) (Indian Scale for Assessment of Autism≥ 70) managed with repetitive Transcranial Magnetic Stimulation (rTMS) once a week for twelve weeks with those managed with identical dosage of placebo, for change in Childhood Autism Rating Scale-2 (CARS-2) scores at 12 weeks of completion of intervention	At 12 weeks of completion of intervention

Secondary Outcome Measures

Name	Time	Method
To compare 6-16-year-old children and adolescents with Autism Spectrum Disorder (ASD) (Indian Scale for Assessment of Autism ≥ 70) managed with repetitive Transcranial Magnetic Stimulation (rTMS) once a week for twelve weeks with those managed with identical dosage of placebo, for change inSocial Communication Questionnaire (SCQ) Scores
To compare 6-16-year-old children and adolescents with Autism Spectrum Disorder (ASD) (Indian Scale for Assessment of Autism ≥ 70) managed with repetitive Transcranial Magnetic Stimulation (rTMS) once a week for twelve weeks with those managed with identical dosage of placebo, for change in	Indian Scale for Assessment of Autism Scores at 12 wks of completion of intervention
To compare 6-16-year-old children and adolescents with Autism Spectrum Disorder (ASD) (Indian Scale for Assessment of Autism ≥ 70) managed with repetitive Transcranial Magnetic Stimulation (rTMS) once a week for twelve weeks with those managed with identical dosage of placebo, for change into compare the change in the Childhood Autism Rating Scale-2 (CARS-2) scores between children in the two groups at 6 months of completion of intervention.

Trial Locations

Locations (2)

Armed Forces Medical College; 🇮🇳 Pune, MAHARASHTRA, India

Army Hospital (R&R); 🇮🇳 Delhi, DELHI, India

Armed Forces Medical College

🇮🇳Pune, MAHARASHTRA, India

Vishal Sondhi

Principal investigator

9560664032

vishalsondhi@gmail.com