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The aim of the study is to assess the effect of left or right high-frequency DTMS on ADHD symptoms, cognitive performance and decision-making ability of ADHD adults, and to compare this to the effect of sham DTMS on ADHD adults
Attention deficit disorder in adults may be due to hypoactivity of prefrontal areas of the brain. Increasing the activity of these areas may help improve symptoms in many of these patients. In addition there is evidence as to dysfunction in both hemispheres of the brain, but it is difficult to determine the contribution of each hemisphere's pattern of activity to behavioral impairment. The purpose of this study is to use high-frequency DTMS to stimulate activity either on the left side of the prefrontal cortex (one arm), or on the right side (a second arm), to see if such stimulation improves attention, comparing to sham DTMS simulation (a third arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation over the left dorsolateral prefrontal cortex | Active Comparator | Group A (fifteen subjects) - treatment by HLPFC coil high-frequency stimulation over the left dorsolateral prefrontal cortex (DLPFC). |
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| stimulation over the right DLPFC | Active Comparator | Group B (fifteen subjects) - Treatment by HLPFC coil high-frequency stimulation over the right DLPFC. |
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| Treatment with HLPFC coil simulator mode | Placebo Comparator | Group C (fifteen subjects) - Treatment with HLPFC coil simulator mode (sham). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment by HLPFC coil | Device | DTMS treatment will be given for 3 weeks, 5 days a week. Before each DTMS treatment, neural network excitation practice will be done using AttenGo software (AttenGo, Herzlia, Israel). Each treatment day: Follow-up to evaluate clinical side effects of treatment. Two additional meetings with DTMS treatment and follow-up will be held to evaluate the efficacy of treatment and side effects. The first will be four weeks after the end of the daily treatment phase; the second eight weeks after the end of the daily treatment phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Conners' Adult ADHD Rating Scale | Screening, at the end of three weeks of treatment, and for each of two follow-up meetings |
| Measure | Description | Time Frame |
|---|---|---|
| Mindstreams Cognitive Tests | Screening, at the end of three weeks of treatment, and for each of two follow-up meetings |
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Inclusion Criteria:
Men and women aged 18-65.
Appropriate diagnosis of ADHD according to DSM-IV criteria:
o DSM-IV criteria require not only that the ADHD symptoms be present now (self-report), but also to have been present in childhood (self-report)
Subjects taking medications for attention deficit disorder will give their consent to stop the drugs from a week before the start of participation in the study, and during the daily treatment phase (four weeks total); subjects also will be asked not to take these medications 24 hours before participation in the review meetings (4 and 8 weeks after the end of the daily treatment phase).
Subjects have given their written and oral consent to participate in research.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elissa Ash, Dr. | Contact | +972-3-6973328 | elissaa@tasmc.health.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel-Aviv Sourasky Medical Center | Recruiting | Tel Aviv | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34215144 | Derived | Bleich-Cohen M, Gurevitch G, Carmi N, Medvedovsky M, Bregman N, Nevler N, Elman K, Ginou A, Zangen A, Ash EL. A functional magnetic resonance imaging investigation of prefrontal cortex deep transcranial magnetic stimulation efficacy in adults with attention deficit/hyperactive disorder: A double blind, randomized clinical trial. Neuroimage Clin. 2021;30:102670. doi: 10.1016/j.nicl.2021.102670. Epub 2021 Apr 18. |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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