High- and low-frequency paired associative deep TMS for ADHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.