rTMS in Children and Adolescents With ADHD:

August 4, 2024 updated by: Marwa Salama Ahmed Omar, Assiut University

High Frequency rTMS in Children and Adolescents With ADHD: a Randomized, Double Blind Clinical Trial.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sixty children with ADHD of both sexes and ages ranging between 8 and 16 years old were included in the study. Randomization of patients: Our patients in each subgroup were randomly allocated to intervention arms (real versus sham) by using serially numbered opaque closed envelopes. Each patient was placed in the appropriate group after opening the corresponding sealed envelope. The official sheet of the assiut university of Psychiatry was used for the assessment and interview. This includes demographic data, personal and family history, medical history, and mental state examination. All subjects were then assessed using the Full psychiatric interview (Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL) to diagnose ADHD and to exclude other diagnoses according to DSM5 classification, which took place in the first interview with the participants before the start of the study. An informed written consent was offered for the parents of the patients participating in the study. All participants were on drugs (stimulants and non-stimulants), and all other medications were stopped 2 weeks before the beginning of the study. Atomoxetine was (from 0.5 to 1.2 mg/ kg/day )(24-25-26) . thirty participants were allocated to the rTMS group who received 15 sessions of rTMS over the right DLPC, in conjunction with Atomoxetine 1.2 mg/kg/day. The other 30 participants were allocated to the Sham control group who received 15 sessions of sham rTMS and atomoxetine 1.2 mg/kg/day. All participants underwent assessments of the severity of ADHD symptoms done at 3 points, before the beginning of treatment (pre), after receiving 15 sessions of rTMS/Sham rTMS (post), and on follow-up 1 month after treatment (FU) (27), using Arabic version Conners' Parent Rating Scale - Revised Long form ,Clinical Global Impression and the resting motor threshold (RMT). The scores pre, post, and follow-up were compared to evaluate the improvement of clinical symptoms, and the therapeutic effects among the 2 groups were also compared. rTMS was delivered through a figure of 8 coil (the outer diameter of each wing is 9 cm, the maximum field strength=1.9 tesla) attached to a Magstim (UK) super rapid magnetic stimulator, (28) which administered at 10 Hz directed to the right dorsolateral prefrontal cortex, located at the F4 location from the EEG 10-20 system. 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) in the active TMS condition. For the sham rTMS, the coil was tilted over the right dorsolateral pre-frontal cortex without touching the scalp. Participants who received less than 75% of the number of sessions (12 sessions) were considered dropouts.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Yaser Mohamed Bader Elden elserogy, professor
  • Phone Number: 01001695708
  • Email: Elserogy@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

.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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Real group
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)
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.
Sham Comparator: Sham control group
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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The resting motor threshold (RMT)
Time Frame: immediately after the end of sessions And follow up 1 month after the end sessions.
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
Time Frame: immediately after the end of sessions And follow up 1 month after the end sessions.
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
Time Frame: immediately after the end of sessions And follow up 1 month after the end sessions.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yaser Mohamed Bader Elden elserogy, professor, processor at psychiatry department at assiut university hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • rTMS in ADHD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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