rTMS in Children and Adolescents With ADHD:

NCT06389864 | Not Yet Recruiting

• 1 other identifier: rTMS in ADHD
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Assess the effect of RTMS on ADHD symptoms and assessment of this effect clinically and objectively.

Conditions

ADHD

Keywords

rTMS,ADHD

Outcome Measures

Primary Outcomes (3)

• The resting motor threshold (RMT)

  was defined, according to the IFCN Committee recommendation, as the lowest stimulus intensity able to elicit MEPs of an amplitude \>50 μV in at least 5 out of 10 trials, with the muscle at rest.

  immediately after the end of sessions And follow up 1 month after the end sessions.

• Arabic version Conners' Parent Rating Scale - Revised Long form

  is applied to detect the core symptoms of ADHD, detect its subtypes, and assess severity. It contains 80 items and can be completed by parents/guardians in approximately 20 minutes.

  immediately after the end of sessions And follow up 1 month after the end sessions.

• Clinical Global Impression CGI

  is designed to assess the effectiveness of a particular treatment: CGI-S assessing Illness Severity and CGI-C assessing Global Improvement or Change.

  immediately after the end of sessions And follow up 1 month after the end sessions.

Study Arms (2)

Real group

ACTIVE COMPARATOR

rTMS administered at 10 Hz directed to the right dorsolateral prefrontal cortex. The pulse intensity was set at 80% of the observed motor threshold, 4 s on-train, 26 s off inter-train interval with 2000 pulses per session(29) for 5 sessions per week, for 15 sessions total (i.e., 30,000 pulses total in treatment course).

Device: rTMS (repetitive transcranial magnetic stimulation)

Sham control group

SHAM COMPARATOR

the rTMS coil was tilted over the right dorsolateral pre-frontal cortex without touching the scalp administered at 10 Hz. The pulse intensity was set at 80% of the observed motor threshold, 4 s on-train, 26 s off inter-train interval with 2000 pulses per session for 5 sessions per week. for 15 sessions total.

Device: rTMS (repetitive transcranial magnetic stimulation)

Interventions

rTMS (repetitive transcranial magnetic stimulation) DEVICE

non invasive repetitive transcranial magnetic stimulation rTMS was administered at 10 Hz directed to the right dorsolateral prefrontal cortex. The pulse intensity was set at 80% of the observed motor threshold, 4 s on-train, 26 s off inter-train interval with 2000 pulses per session for 5 sessions per week, for 15 sessions total (i.e., 30,000 pulses total in treatment course) in the active TMS condition. For the sham rTMS, the coil was tilted over the right dorsolateral pre-frontal cortex without touching the scalp.

Real group; Sham control group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of ADHD met the diagnostic criteria for ADHD in the (DSM-5) of the American Psychiatric association.
• Must be able to swallow tablets.
• both sexes will be included in the study.
• Age will be 6-18 years.
• IQ≥70.

You may not qualify if:

• comorbid diagnosis of autism spectrum disorder, bipolar disorder, obsessive-compulsive disorder, conduct disorder, Tourette disorder or other tic disorders, schizophrenia, schizoaffective disorder, any other psychotic disorder or other.
• contraindications to magnetic stimulation such as any metallic object implanted in the skull (except for oral dental devices), an implanted medication pump or cochlear implant, implanted intra-cardiac lines or pacemaker.
• increase the risk of seizure with TMS such as a history of a seizure disorder, febrile seizures during childhood, known brain lesions, or a history of major head trauma involving loss of consciousness for more than 5 min were excluded from the study.
• major neurological deficits, disease, cerebral palsy other heart, liver, lung, kidney, or other serious somatic diseases.
• other medications or other treatment rather than treatment for ADHD. .Mood regulating medications within 14 days. .recent treatment with TMS.
• refuse to participate in the study or their caregiver refusing to give informed consent.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Thomas R, Sanders S, Doust J, Beller E, Glasziou P. Prevalence of attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. Pediatrics. 2015 Apr;135(4):e994-1001. doi: 10.1542/peds.2014-3482. Epub 2015 Mar 2.

  PMID: 25733754 BACKGROUND

• Biederman J, Spencer T, Wilens T. Evidence-based pharmacotherapy for attention-deficit hyperactivity disorder. Int J Neuropsychopharmacol. 2004 Mar;7(1):77-97. doi: 10.1017/S1461145703003973. Epub 2004 Jan 21.

  PMID: 14733627 BACKGROUND

• Thapar A, Cooper M. Attention deficit hyperactivity disorder. Lancet. 2016 Mar 19;387(10024):1240-50. doi: 10.1016/S0140-6736(15)00238-X. Epub 2015 Sep 17.

  PMID: 26386541 BACKGROUND

• Fitzgerald PB, Fountain S, Daskalakis ZJ. A comprehensive review of the effects of rTMS on motor cortical excitability and inhibition. Clin Neurophysiol. 2006 Dec;117(12):2584-96. doi: 10.1016/j.clinph.2006.06.712. Epub 2006 Aug 4.

  PMID: 16890483 BACKGROUND

• Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997 Jul;36(7):980-8. doi: 10.1097/00004583-199707000-00021.

  PMID: 9204677 BACKGROUND

• Kumar G, Steer RA. Factorial validity of the Conners' Parent Rating Scale-revised: short form with psychiatric outpatients. J Pers Assess. 2003 Jun;80(3):252-9. doi: 10.1207/S15327752JPA8003_04.

  PMID: 12763699 BACKGROUND

• Kujirai T, Caramia MD, Rothwell JC, Day BL, Thompson PD, Ferbert A, Wroe S, Asselman P, Marsden CD. Corticocortical inhibition in human motor cortex. J Physiol. 1993 Nov;471:501-19. doi: 10.1113/jphysiol.1993.sp019912.

  PMID: 8120818 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Yaser Mohamed Bader Elden elserogy, professor

  processor at psychiatry department at assiut university hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa SA assistant lecturer

CONTACT

01006173585; marwasalama9252@gmail.com

Yaser Mohamed Bader Elden elserogy, professor

CONTACT

01001695708; Elserogy@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer at psychiatric department at assiut university hospital

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 29, 2024
• Study Start: October 10, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08