High- and low-frequency paired associative deep TMS for ADHD
Randomized, Sham Controlled Study for the Treatment of ADHD Using High and Low Frequency Paired Associative Deep Transcranial Magnetic Stimulation
This trial tests whether high- or low-frequency paired deep transcranial magnetic stimulation (dTMS) to the prefrontal cortex can help adults with ADHD by balancing cortical arousal between the brain hemispheres.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ben-Gurion University of the Negev Academic / other |
| Locations | 1 site (Beersheba) |
| Trial ID | NCT07105475 on ClinicalTrials.gov |
What this trial studies
This interventional study will enroll 90 adults with DSM-5 ADHD and assign participants to high-frequency paired associative stimulation, low-frequency paired stimulation, or a sham condition. Participants will receive daily deep TMS sessions for three weeks, with follow-up visits at 4 and 8 weeks after treatment. Outcomes include electrophysiological measures (EEG), cognitive testing, and clinical symptom scales such as the CAARS to capture short- and longer-term changes. The protocol targets right-to-left prefrontal paired stimulation with the aim of normalizing hemispheric arousal asymmetry.
Who should consider this trial
Good fit: Adults aged 21–65 with a DSM-5 diagnosis of ADHD who can attend daily treatment sessions and follow the medication timing protocol are the intended participants.
Not a fit: People with contraindications to TMS (for example a history of seizures, implanted metallic or electronic devices, or cardiac pacemakers), children, or those unable to follow the medication/timing requirements may not receive benefit.
Why it matters
Potential benefit: If successful, the approach could reduce ADHD symptoms by restoring more balanced prefrontal cortical arousal and improving attention and impulse control.
How similar studies have performed: Noninvasive TMS has produced mixed but promising results in ADHD, while paired associative deep TMS is a newer, less-tested variant with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women aged 21-65. * 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: * Additional active psychiatric disorders in Axis I of the DSM-5. * 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.
Where this trial is running
Beersheba
- Ben Gurion University of the Negev — Beersheba, Israel (Recruiting)
Study contacts
- Principal investigator: Hadar Shalev — Soroka University Medical Center
- Study coordinator: Abraham Zangen
- Email: azangen@bgu.ac.il
- Phone: +972 8-647-2646
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.