Attention Deficit Hyperactivity DisorderNCT07105475
Treatment of ADHD Using High and Low Frequency Paired Associative Deep Transcranial Magnetic Stimulation
A study testing Paired Associative Transcranial Magnetic Stimulation (TMS) in people with Attention Deficit Hyperactivity Disorder and Neurodevelopmental Disorders, run by Ben-Gurion University of the Negev at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders, Prefrontal Cortex Dysregulation
- What is being tested?
- Paired Associative Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Jul 2023to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Ben Gurion University of the Negev
Beersheba
Abraham Zangen, +972 8-647-2646, azangen@bgu.ac.il
About this study
Official title: Randomized, Sham Controlled Study for the Treatment of ADHD Using High and Low Frequency Paired Associative Deep Transcranial Magnetic Stimulation
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.
Read the detailed description
Introduction Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that uses magnetic fields to stimulate nerve cells in the brain, potentially altering brain activities and influencing behavior. It has been applied in both healthy individuals and patients to study brain activity, behavior, and therapeutic effects. TMS can be administered as single pulses or repetitive stimuli, with the latter showing lasting effects beyond the treatment session. High-frequency TMS is FDA-approved for treating major depressive disorder, obsessive-compulsive disorder, and smoking cessation.
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
- Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders, Prefrontal Cortex Dysregulation, Cortical Arousal Imbalance
- Being tested
- Paired Associative Transcranial Magnetic Stimulation (TMS)
- Keywords
- ADHD, Transcranial Magnetic Stimulation (TMS), Paired Associative Stimulation (PAS), Prefrontal Cortex, Hemispheric Asymmetry
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paired Associative Transcranial Magnetic Stimulation (TMS)Device
Also called Low-Frequency Paired Associative Stimulation (PAS), High-Frequency Paired Associative Stimulation (PAS)
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Frequency Active PAS Treatment (ADHD Patients) | Experimental | 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. Receives: Device: Paired Associative Transcranial Magnetic Stimulation (TMS) |
| High-Frequency Active PAS Treatment (ADHD Patients) | Experimental | 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. Receives: Device: Paired Associative Transcranial Magnetic Stimulation (TMS) |
| Low-Frequency Sham PAS Treatment (ADHD Patients) | Placebo comparator | 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. Receives: Device: Paired Associative Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADHD Symptoms Assessed by the Conners' Adult ADHD Rating Scale (CAARS)
This measure evaluates the change in ADHD symptom severity using the Conners' Adult ADHD Rating Scale (CAARS), a standardized and validated assessment tool. The CAARS provides subscale scores (e.g., Inattention, Hyperactivity-Impulsivity, ADHD Index) on a scale ranging from 0 to 100, with higher scores indicating greater symptom severity. Change will be assessed by comparing scores obtained at baseline (pre-treatment) and following the intervention (post-treatment), as well as at 1-month and 2-month follow-up visits.
Measured: Pre-treatment (baseline) and post-treatment assessments at the end of the 3-week treatment phase, with follow-up assessments at 1 month and 2 months after treatment to evaluate sustained symptom improvement.
Change in Cognitive Control Assessed by Stroop Task Performance
This measure assesses changes in participants' cognitive control by comparing pre-treatment and post-treatment performance on the Stroop Task. Performance is evaluated based on reaction time (milliseconds) and accuracy (% correct responses) in congruent and incongruent trials. Lower reaction times and higher accuracy typically indicate better cognitive control, but outcome-neutral interpretation will be used to assess change.
Measured: Pre-treatment (baseline) and post-treatment (immediately after the 3-week treatment phase). Additional assessments may be conducted during follow-up sessions at 1 month and 2 months after treatment.
Change in Working Memory Assessed by N-back Task Performance
This measure evaluates working memory by comparing participants' pre-treatment and post-treatment performance on the N-back task (2-back condition). Performance is quantified by reaction time (milliseconds) and accuracy (% correct target detections). Lower reaction times and higher accuracy reflect stronger working memory performance, but results will be analyzed in a directionally neutral manner.
Measured: Pre-treatment (baseline) and post-treatment (immediately after the 3-week treatment phase). Additional assessments may be conducted during follow-up sessions at 1 month and 2 months after treatment.
Change in EEG Power Spectral Density Across Frequency Bands
This outcome assesses changes in EEG power spectral density (PSD) in the delta (0.5-4 Hz), theta (4-7 Hz), alpha (8-12 Hz), and beta (13-30 Hz) frequency bands during resting-state EEG. PSD will be calculated using Fourier-based spectral analysis and reported in microvolts squared per hertz (µV²/Hz) at frontal and motor cortex sites.
Measured: Baseline (pre/post Session 1), end of treatment (pre/post Session 15), and at 1-month and 2-month follow-ups. EEG is recorded during rest, cognitive tasks, TMS, TEP, and post-treatment rest at each time point.
Change in Raw EEG Voltage
This outcome measures the overall amplitude of raw EEG signals recorded at rest. Changes in baseline EEG voltage levels will be evaluated across treatment sessions and follow-ups to assess general cortical excitability. Unit of Measure:
Microvolts (µV).
Measured: Baseline (pre/post Session 1), end of treatment (pre/post Session 15), and at 1-month and 2-month follow-ups. EEG is recorded during rest, cognitive tasks, TMS, TEP, and post-treatment rest at each time point.
Secondary outcomes (6)
Long-Term Change in ADHD Symptoms Assessed at Follow-Up by Conners' Adult ADHD Rating Scale (CAARS)
This outcome assesses the persistence of treatment-related changes in ADHD symptoms using the Conners' Adult ADHD Rating Scale (CAARS). The CAARS includes multiple subscale scores (e.g., Inattention, Hyperactivity-Impulsivity) ranging from 0 to 100, with higher scores indicating greater symptom severity. Scores will be compared between post-treatment and follow-up time points to evaluate sustained changes. Unit of Measure: CAARS Subscale Score (0-100).
Measured: Assessed during follow-up sessions at 1 month and 2 months after the end of the 3-week treatment phase to evaluate the persistence of treatment effects.
Long-Term Change in Cognitive Control Assessed at Follow-Up by Stroop Task Performance
This outcome evaluates long-term effects of TMS on cognitive control using the Stroop Task. Performance will be measured by reaction time (milliseconds) and accuracy (% correct responses) during congruent and incongruent trials. Comparisons will be made between post-treatment and follow-up time points to assess sustained changes in executive function. Unit of Measure: Milliseconds (reaction time), Percent correct (% accuracy).
Measured: Assessed during follow-up sessions at 1 month and 2 months after the end of the 3-week treatment phase to evaluate the persistence of treatment effects.
Long-Term Change in Working Memory Assessed at Follow-Up by N-back Task Performance
This outcome evaluates the persistence of treatment-related changes in working memory using the 2-back condition of the N-back Task. Performance will be assessed based on reaction time (milliseconds) and accuracy (% correct target detections). Results from post-treatment and follow-up assessments will be compared. Unit of Measure: Milliseconds (reaction time), Percent correct (% accuracy).
Measured: Assessed during follow-up sessions at 1 month and 2 months after the end of the 3-week treatment phase to evaluate the persistence of treatment effects.
Change in Amplitude of TMS-Evoked Potential (TEP) Components
This outcome assesses the amplitude of specific TMS-evoked potential (TEP) components (e.g., P30, N45, N100) extracted from EEG data recorded during TMS stimulation sessions. These components reflect cortical excitability and inhibition. Unit of Measure: Microvolts (µV).
Measured: Baseline (pre/post Session 1), end of treatment (pre/post Session 15), and at 1-month and 2-month follow-ups. EEG is recorded during rest, cognitive tasks, TMS, TEP, and post-treatment rest at each time point.
Change in Variance of TMS-Evoked Potentials (TEPs)
This outcome quantifies the trial-by-trial variability of TEP responses to assess consistency of cortical reactivity. Variance in EEG response to TMS will be calculated for each major TEP component. Unit of Measure: Microvolts squared (µV²).
Measured: Baseline (pre/post Session 1), end of treatment (pre/post Session 15), and at 1-month and 2-month follow-ups. EEG is recorded during rest, cognitive tasks, TMS, TEP, and post-treatment rest at each time point.
Change in EEG Frequency Characteristics
This outcome tracks shifts in peak and dominant frequency within delta, theta, alpha, and beta bands during resting EEG. It provides insight into general neurophysiological state and functional changes over time. Unit of Measure: Hertz (Hz).
Measured: Baseline (pre/post Session 1), end of treatment (pre/post Session 15), and at 1-month and 2-month follow-ups. EEG is recorded during rest, cognitive tasks, TMS, TEP, and post-treatment rest at each time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start19 Jul 2023
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ben-Gurion University of the Negev
- Sponsor type
- University, hospital or other
- Collaborators
- Soroka University Medical Center
- Responsible party
- Principal investigator, Zachary Katz, Ben-Gurion University of the Negev
- Investigators
- Abraham Zangen, Study director, Ben-Gurion University of the NegevHadar Shalev, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105475
- Sponsor's protocol ID
- 0152-23-SOR
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Sham Controlled Study for the Treatment of ADHD Using High and Low Frequency Paired Associative Deep Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT07105475
- Acronym / sponsor ID
- 0152-23-SOR
- Conditions
- Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders, Prefrontal Cortex Dysregulation, Cortical Arousal Imbalance
- Keywords
- ADHD, Transcranial Magnetic Stimulation (TMS), Paired Associative Stimulation (PAS), Prefrontal Cortex, Hemispheric Asymmetry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ben-Gurion University of the NegevUniversity, hospital or other
- Collaborators
- Soroka University Medical Center
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that uses magnetic fields to stimulate nerve cells in the brain, potentially altering brain activities and influencing behavior. It has been applied in both healthy individuals and patients to study brain activity, behavior, and therapeutic effects. TMS can be administered as single pulses or repetitive stimuli, with the latter showing lasting effects beyond the treatment session. High-frequency TMS is FDA-approved for treating major depressive disorder, obsessive-compulsive disorder, and smoking cessation.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Frequency Active PAS Treatment (ADHD Patients) | Experimental | Device: Paired Associative Transcranial Magnetic Stimulation (TMS)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. |
| High-Frequency Active PAS Treatment (ADHD Patients) | Experimental | Device: Paired Associative Transcranial Magnetic Stimulation (TMS)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. |
| Low-Frequency Sham PAS Treatment (ADHD Patients) | Placebo comparator | Device: Paired Associative Transcranial Magnetic Stimulation (TMS)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paired Associative Transcranial Magnetic Stimulation (TMS)Also: Low-Frequency Paired Associative Stimulation (PAS), High-Frequency Paired Associative Stimulation (PAS)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. | Device | High-Frequency Active PAS Treatment (ADHD Patients), Low-Frequency Active PAS Treatment (ADHD Patients), Low-Frequency Sham PAS Treatment (ADHD Patients) |
Primary outcome
Change in ADHD Symptoms Assessed by the Conners' Adult ADHD Rating Scale (CAARS)
Time frame: Pre-treatment (baseline) and post-treatment assessments at the end of the 3-week treatment phase, with follow-up assessments at 1 month and 2 months after treatment to evaluate sustained symptom improvement.
This measure evaluates the change in ADHD symptom severity using the Conners' Adult ADHD Rating Scale (CAARS), a standardized and validated assessment tool. The CAARS provides subscale scores (e.g., Inattention, Hyperactivity-Impulsivity, ADHD Index) on a scale ranging from 0 to 100, with higher scores indicating greater symptom severity. Change will be assessed by comparing scores obtained at baseline (pre-treatment) and following the intervention (post-treatment), as well as at 1-month and 2-month follow-up visits.
Change in Cognitive Control Assessed by Stroop Task Performance
Time frame: Pre-treatment (baseline) and post-treatment (immediately after the 3-week treatment phase). Additional assessments may be conducted during follow-up sessions at 1 month and 2 months after treatment.
This measure assesses changes in participants' cognitive control by comparing pre-treatment and post-treatment performance on the Stroop Task. Performance is evaluated based on reaction time (milliseconds) and accuracy (% correct responses) in congruent and incongruent trials. Lower reaction times and higher accuracy typically indicate better cognitive control, but outcome-neutral interpretation will be used to assess change.
Change in Working Memory Assessed by N-back Task Performance
Time frame: Pre-treatment (baseline) and post-treatment (immediately after the 3-week treatment phase). Additional assessments may be conducted during follow-up sessions at 1 month and 2 months after treatment.
This measure evaluates working memory by comparing participants' pre-treatment and post-treatment performance on the N-back task (2-back condition). Performance is quantified by reaction time (milliseconds) and accuracy (% correct target detections). Lower reaction times and higher accuracy reflect stronger working memory performance, but results will be analyzed in a directionally neutral manner.
Change in EEG Power Spectral Density Across Frequency Bands
Time frame: Baseline (pre/post Session 1), end of treatment (pre/post Session 15), and at 1-month and 2-month follow-ups. EEG is recorded during rest, cognitive tasks, TMS, TEP, and post-treatment rest at each time point.
This outcome assesses changes in EEG power spectral density (PSD) in the delta (0.5-4 Hz), theta (4-7 Hz), alpha (8-12 Hz), and beta (13-30 Hz) frequency bands during resting-state EEG. PSD will be calculated using Fourier-based spectral analysis and reported in microvolts squared per hertz (µV²/Hz) at frontal and motor cortex sites.
Change in Raw EEG Voltage
Time frame: Baseline (pre/post Session 1), end of treatment (pre/post Session 15), and at 1-month and 2-month follow-ups. EEG is recorded during rest, cognitive tasks, TMS, TEP, and post-treatment rest at each time point.
This outcome measures the overall amplitude of raw EEG signals recorded at rest. Changes in baseline EEG voltage levels will be evaluated across treatment sessions and follow-ups to assess general cortical excitability. Unit of Measure: Microvolts (µV).
6 secondary outcomes
Long-Term Change in ADHD Symptoms Assessed at Follow-Up by Conners' Adult ADHD Rating Scale (CAARS)
Time frame: Assessed during follow-up sessions at 1 month and 2 months after the end of the 3-week treatment phase to evaluate the persistence of treatment effects.
Long-Term Change in Cognitive Control Assessed at Follow-Up by Stroop Task Performance
Time frame: Assessed during follow-up sessions at 1 month and 2 months after the end of the 3-week treatment phase to evaluate the persistence of treatment effects.
Long-Term Change in Working Memory Assessed at Follow-Up by N-back Task Performance
Time frame: Assessed during follow-up sessions at 1 month and 2 months after the end of the 3-week treatment phase to evaluate the persistence of treatment effects.
Change in Amplitude of TMS-Evoked Potential (TEP) Components
Time frame: Baseline (pre/post Session 1), end of treatment (pre/post Session 15), and at 1-month and 2-month follow-ups. EEG is recorded during rest, cognitive tasks, TMS, TEP, and post-treatment rest at each time point.
Change in Variance of TMS-Evoked Potentials (TEPs)
Time frame: Baseline (pre/post Session 1), end of treatment (pre/post Session 15), and at 1-month and 2-month follow-ups. EEG is recorded during rest, cognitive tasks, TMS, TEP, and post-treatment rest at each time point.
Change in EEG Frequency Characteristics
Time frame: Baseline (pre/post Session 1), end of treatment (pre/post Session 15), and at 1-month and 2-month follow-ups. EEG is recorded during rest, cognitive tasks, TMS, TEP, and post-treatment rest at each time point.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abraham Zangen study director
Ben-Gurion University of the Negev
Hadar Shalev principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paired Associative Transcranial Magnetic Stimulation (TMS) in people with Attention Deficit Hyperactivity Disorder and Neurodevelopmental Disorders, run by Ben-Gurion University of the Negev at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abraham Zangen (+972 8-647-2646, azangen@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ADHD Symptoms Assessed by the Conners' Adult ADHD Rating Scale (CAARS) (time frame: Pre-treatment (baseline) and post-treatment assessments at the end of the 3-week treatment phase, with follow-up assessments at 1 month and 2 months after treatment to evaluate sustained symptom improvement.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.