Treatment of ADHD Using High and Low Frequency Paired Associative Deep Transcranial Magnetic Stimulation
NCT ID: NCT07105475
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
90 participants
INTERVENTIONAL
2023-07-19
2028-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Deep Transcranial Magnetic Stimulation (DTMS) as a Treatment for Attention Deficit Hyperactivity Disorder (ADHD) in Adults
NCT01196910
A Double Blind Randomized Controlled Evaluation of the HBLPADD-coil Transcranial Magnetic Stimulation (TMS) Device - Efficacy and Safety In Subjects With ADHD.
NCT01723319
Non Invasive Brain Stimulation Effects on Attentional Performance in ADHD Adults
NCT02286349
Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease
NCT00753662
ADHD PreSMA Response Inhibition Therapy
NCT06325813
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
ADHD is a neurodevelopmental disorder characterized by inattention, impulsivity, and hyperactivity. Neuroimaging studies have identified deficits in brain regions such as the prefrontal cortex, basal ganglia, and cerebellum in ADHD patients. Enhancing activity in these areas, particularly the prefrontal cortex, through high-frequency TMS has shown promise in reducing ADHD symptoms.
Research Question and Hypothesis The study aims to assess the effectiveness of paired associative stimulation (PAS) in treating ADHD. It hypothesizes that right-to-left prefrontal paired stimulation can enhance cortical arousal and provide symptom relief. The study includes two active treatment groups (high and low-frequency PAS) and a sham treatment group, with secondary goals to quantify short- and long-term changes in behavior, brain function, and structure.
Methods
Participants Total: 90 ADHD patients ADHD patients: Pre-screened by a psychiatrist; will undergo three weeks of treatment.
Healthy controls: Single session to measure brain activity and arousal.
Length of Experiment Recruitment duration: Approximately three years to recruit 90 ADHD subjects. Individual participation: Three weeks of treatment, with follow-up sessions at one and two months post-treatment.
Procedure Patient recruitment: Includes medical screening, consent, physical and neurological examinations, and psychological assessments.
Experimental Groups:
Group A: Low-frequency active PAS (30 ADHD subjects). Group B: High-frequency active PAS (30 ADHD subjects). Group C: Low-frequency sham PAS (30 ADHD subjects).
Daily Magnetic Therapy Phase 15 TMS treatments over three weeks for ADHD subjects, including cognitive exercises post-TMS. Data collection includes EEG recordings, cognitive tests, and brain response measurements before and after TMS.
Follow-up Phase Two sessions, four weeks apart, assessing treatment effectiveness and side effects through EEG and questionnaires.
Conclusion This study explores the potential of high and low-frequency paired associative dTMS in treating ADHD by targeting interhemispheric balance in the prefrontal cortex. The research will provide insights into the efficacy of PAS as an innovative treatment approach for ADHD.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low-Frequency Active PAS Treatment (ADHD Patients)
Participants in this group will undergo three weeks of low-frequency paired associative stimulation (PAS) treatment. This involves the application of TMS at a low frequency to stimulate brain areas, specifically targeting the prefrontal cortex, to potentially improve symptoms of ADHD. The treatment will be administered five days a week for three weeks.
Paired Associative Transcranial Magnetic Stimulation (TMS)
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that uses magnetic fields to stimulate nerve cells in the brain. By placing a coil on the scalp, TMS generates magnetic pulses that induce electrical currents in specific brain regions. This can alter brain activity and potentially influence behavior and symptoms of various neurological and psychiatric conditions.
PAS involves the use of transcranial magnetic stimulation (TMS) at a low and high frequency to stimulate the prefrontal cortex at different areas of the brain. The goal is to assess its effects on cortical arousal and ADHD symptoms. Participants will receive daily sessions of this stimulation for three weeks, with the stimulation designed to influence brain activity and potentially alleviate symptoms of ADHD.
High-Frequency Active PAS Treatment (ADHD Patients)
Participants in this group will receive three weeks of high-frequency PAS treatment. High-frequency TMS will be applied to stimulate brain areas, particularly the prefrontal cortex, to enhance cortical arousal and improve ADHD symptoms. This treatment will also be administered five days a week for three weeks.
Paired Associative Transcranial Magnetic Stimulation (TMS)
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that uses magnetic fields to stimulate nerve cells in the brain. By placing a coil on the scalp, TMS generates magnetic pulses that induce electrical currents in specific brain regions. This can alter brain activity and potentially influence behavior and symptoms of various neurological and psychiatric conditions.
PAS involves the use of transcranial magnetic stimulation (TMS) at a low and high frequency to stimulate the prefrontal cortex at different areas of the brain. The goal is to assess its effects on cortical arousal and ADHD symptoms. Participants will receive daily sessions of this stimulation for three weeks, with the stimulation designed to influence brain activity and potentially alleviate symptoms of ADHD.
Low-Frequency Sham PAS Treatment (ADHD Patients)
This group will undergo three weeks of sham PAS treatment, where the procedure mimics the active treatment but with the magnetic stimulation at a minimal power (20% of the subject's motor threshold). The goal is to serve as a placebo control to evaluate the effectiveness of the active treatments. This sham treatment will be administered five days a week for three weeks.
Paired Associative Transcranial Magnetic Stimulation (TMS)
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that uses magnetic fields to stimulate nerve cells in the brain. By placing a coil on the scalp, TMS generates magnetic pulses that induce electrical currents in specific brain regions. This can alter brain activity and potentially influence behavior and symptoms of various neurological and psychiatric conditions.
PAS involves the use of transcranial magnetic stimulation (TMS) at a low and high frequency to stimulate the prefrontal cortex at different areas of the brain. The goal is to assess its effects on cortical arousal and ADHD symptoms. Participants will receive daily sessions of this stimulation for three weeks, with the stimulation designed to influence brain activity and potentially alleviate symptoms of ADHD.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Paired Associative Transcranial Magnetic Stimulation (TMS)
Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that uses magnetic fields to stimulate nerve cells in the brain. By placing a coil on the scalp, TMS generates magnetic pulses that induce electrical currents in specific brain regions. This can alter brain activity and potentially influence behavior and symptoms of various neurological and psychiatric conditions.
PAS involves the use of transcranial magnetic stimulation (TMS) at a low and high frequency to stimulate the prefrontal cortex at different areas of the brain. The goal is to assess its effects on cortical arousal and ADHD symptoms. Participants will receive daily sessions of this stimulation for three weeks, with the stimulation designed to influence brain activity and potentially alleviate symptoms of ADHD.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aligned with the diagnosis of ADHD according to the criteria of the DSM-5.
* Participants taking medication for the treatment of attention deficit hyperactivity disorder will be asked, starting one week before the start of the treatment until the end, to take Ritalin IR 10mg (provided that the taking of the medication will be done at least 8 hours before the start of the treatment or at least one hour after it. This instruction is also valid for taking the medication on the days of the follow-up sessions (4 and 8 weeks from the end of the daily treatment phase). Ritalin is given as the only option because a drug with a short half-life is needed. The dose can be increased up to 20 mg per dose). The choice of this drug is to ensure that changes in brain function/activity are not the result of the Ritalin medication but of the research intervention.
* Give their written and oral consent to participate in the study.
Exclusion Criteria
* Antipsychotic treatment, antidepressants, or mood stabilizers.
* History of intolerance to TMS.
* Diagnosis of severe personality disorder according to the DSM-5.
* Current suicidal tendency.
* High and uncontrolled blood pressure.
* History of epilepsy, seizures or febrile seizures.
* History of epilepsy or seizures in first degree relatives.
* History of a head injury or major stroke that produced impairment.
* History of metal in the head (outside the oral cavity).
* History of surgery involving metal implants or a known history of metal particles in the eye, pacemakers, hearing aid implantation, use of neurostimulators, or any medical pump.
* History of drug or alcohol addiction.
* Inability to adequately communicate with the examiner.
* Participation in another medical study at the time of conducting the experiment or 3 months before it.
* Inability of the subject to sign a consent form.
* Pregnancy or not giving a commitment not to get pregnant during the study period or having sex without using contraceptives.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Soroka University Medical Center
OTHER
Ben-Gurion University of the Negev
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zachary Katz
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Abraham Zangen
Role: STUDY_DIRECTOR
Ben-Gurion University of the Negev
Hadar Shalev
Role: PRINCIPAL_INVESTIGATOR
Soroka University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ben Gurion University of the Negev
Beersheba, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0152-23-SOR
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.