RecruitingNot ApplicableNCT07105475

Treatment of ADHD Using High and Low Frequency Paired Associative Deep Transcranial Magnetic Stimulation

Randomized, Sham Controlled Study for the Treatment of ADHD Using High and Low Frequency Paired Associative Deep Transcranial Magnetic Stimulation

Sponsor

Ben-Gurion University of the Negev

Enrollment

90 participants

Start Date

Jul 19, 2023

Study Type

INTERVENTIONAL

Conditions

Neurodevelopmental Disorders Attention Deficit Hyperactivity Disorder Prefrontal Cortex Dysregulation Cortical Arousal Imbalance

Summary

This study investigates the effects of high and low-frequency paired associative deep transcranial magnetic stimulation (dTMS) on adults with Attention Deficit Hyperactivity Disorder (ADHD). The study aims to explore whether targeting the prefrontal cortex with paired stimulation can improve symptoms of ADHD by balancing cortical arousal between the brain hemispheres. A total of 90 participants with ADHD will be recruited. Participants with ADHD will undergo three weeks of daily TMS treatment, while participants who receive a sham treatment will be included for baseline comparisons. The study will measure electrophysiological, cognitive, and clinical outcomes using a variety of assessments, including EEG, cognitive tests, and CAARS to evaluate the treatment's efficacy.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

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 Criteria16

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.

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Interventions

DEVICEPaired 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.