ADHDNCT06389864
rTMS in Children and Adolescents With ADHD:
A study testing rTMS (repetitive transcranial magnetic stimulation) in people with ADHD, run by Assiut University.
Trial summary
Assess the effect of RTMS on ADHD symptoms and assessment of this effect clinically and objectively. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- rTMS (repetitive transcranial magnetic stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- .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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- ADHD
- Being tested
- rTMS (repetitive transcranial magnetic stimulation)
- Keywords
- rTMS,ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: rTMS (repetitive transcranial magnetic stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: immediately after the end of sessions And follow up 1 month after the end sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start10 Oct 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Salama Ahmed Omar, Assiut University
- Investigators
- Yaser Mohamed Bader Elden elserogy, professor, Principal investigator, processor at psychiatry department at assiut university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389864
- Sponsor's protocol ID
- rTMS in ADHD
- Status last verified
- Aug 2024
- First submitted
- 2 Apr 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25733754Biederman 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.
PubMed 14733627Thapar 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.
PubMed 26386541Fitzgerald 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.
PubMed 16890483Kaufman 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.
PubMed 9204677Kumar 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.
PubMed 12763699Kujirai 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.
PubMed 8120818
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency rTMS in Children and Adolescents With ADHD: a Randomized, Double Blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT06389864
- Acronym / sponsor ID
- rTMS in ADHD
- Conditions
- ADHD
- Keywords
- rTMS,ADHD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the effect of RTMS on ADHD symptoms and assessment of this effect clinically and objectively.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real group | Active comparator | Device: rTMS (repetitive transcranial magnetic stimulation)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). |
| Sham control group | Sham comparator | Device: rTMS (repetitive transcranial magnetic stimulation)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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- .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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Real group, Sham control group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Background: PubMed 25733754Thomas 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.
- Background: PubMed 14733627Biederman 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.
- Background: PubMed 26386541Thapar 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.
- Background: PubMed 16890483Fitzgerald 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.
- Background: PubMed 9204677Kaufman 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.
- Background: PubMed 12763699Kumar 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.
- Background: PubMed 8120818Kujirai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yaser Mohamed Bader Elden elserogy, professor principal investigator
processor at psychiatry department at assiut university hospital
Questions about this trial
What is this clinical trial studying?
A study testing rTMS (repetitive transcranial magnetic stimulation) in people with ADHD, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa SA assistant lecturer (01006173585, marwasalama9252@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The resting motor threshold (RMT) (time frame: immediately after the end of sessions And follow up 1 month after the end sessions.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06389864, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.