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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Israel
Ben Gurion University of the Negev
RECRUITING
Beersheba
Contact Information
Primary
Abraham Zangen
azangen@bgu.ac.il
+972 8-647-2646
Time Frame
Start Date: 2023-07-19
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 90
Treatments
Experimental: 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.
Experimental: 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.
Placebo_comparator: 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.
Sponsors
Leads: Ben-Gurion University of the Negev
Collaborators: Soroka University Medical Center

This content was sourced from clinicaltrials.gov