Transcranial Magnetic Stimulation for Attention Deficit/Hyperactivity Disorder (ADHD)
Attention Deficit Disorder With Hyperactivity (ADHD)
Bottom Line
View on ClinicalTrials.gov: NCT03663179 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Magnetic Stimulation (TMS) (Device); Sham Transcranial Magnetic Stimulation (Sham TMS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Performance on Conners Adult ADHD Rating Scale - Self-Report: Long Version (ADHD Symptoms) |
-4.4; -5.1 | — |
| SECONDARY Change in Performance on Conners Continuous Performance Task (Sustained Attention) |
-16.2; -4.8 | — |
Summary
Eligibility Criteria
Inclusion Criteria
Eligible participants will be:
- Healthy males and females who are between 18 and 65 years of age with an ADHD diagnosis (meet diagnostic criteria for ADHD on the SCID-5 module for adult ADHD).
- Planning to live in the area for at least the next 6 weeks;
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form;
- Able to communicate fluently in English (speaking, writing, and reading).
Exclusion Criteria
Subjects who present and/or self-report with the following criteria at any point during study participation will not be eligible to participate in the study:
Alcohol/Drugs:
- History or current diagnosis or treatment for alcohol or drug abuse (as reported during phone screen);
- Positive breath alcohol concentration test (BrAC greater than or equal to 0.01) at intake;
- A positive urine drug screen for cocaine, phencyclidine (PCP), amphetamines, methamphetamines, benzodiazepines, methadone, and/or barbiturates at Intake, Baseline, or Sessions 5, 10, 15 or 20.
Medication:
Current use or recent discontinuation (within the past 6 months at the time of Intake) of:
- Gamma-Aminobutyric Acid (GABA)-ergic medications
- Glutamatergic medications
- Any medication for the treatment of ADHD
- Benzodiazepines
- Any medication that is known to lower the seizure threshold (e.g.,clozapine, bupropion, tramadol, carbapenems, stimulants)
- Any medication that could compromise participant safety as determined by the Principal Investigator and/or Study Physician
Current use or recent discontinuation (within the last 14 days at the time of Intake) of:
- Anti-psychotic medications
- Nicotine replacement therapy (NRT)
Daily use of:
- Opiate-containing medications for chronic pain
Medical/Neuropsychiatric:
- Women who are pregnant, planning a pregnancy, and/or breast feeding.
- History of seizures, epilepsy, or history of epilepsy in first-degree relative
- History of stroke or transient ischemic attack (warning stroke)
- History of traumatic brain injury or self-report of brain or spinal tumor
- History of head injury with unconsciousness lasting more than 5 minutes
- Previous brain surgery
- Any additional neurological condition that would likely reduce the safety of study participation, including central nervous system (CNS) vasculitis, intracranial tumor, intracranial aneurysm, multiple sclerosis or arteriovenous malformations
- History of tinnitus
- History of diabetes mellitus
- History of atherosclerotic vascular disease
- A medically unstable cardiopulmonary or metabolic disorder
- Increased risk for myocardial infarction or other major cardiopulmonary complications.
- Any uncorrected visual impairment or abnormality
- Self-reported history, current diagnosis of psychosis or symptoms consistent with a mood disorder based upon the Structured Clinical Interview for DSM-5 (SCID); including schizophrenia, mania, bipolar disorder, an eating disorder, obsessive compulsive disorder, an anxiety disorder, major depression (subjects with a history of major depression but in remission for past 6 months are eligible).
TMS-related:
- Subjects with ferromagnetic material in or in close proximity to the head (with the exception of oral dental devices)
- Implanted devices (including vagus nerve stimulator (VNS), deep brain stimulator (DBS), pacemakers, spinal cord stimulators, medication pumps, ventriculo peritoneal shunts, defibrillators, intracardiac lines)
- Self-report of any skull fracture or opening
- A disturbance in normal sleep patterns/sleep deprivation
General Exclusion:
- Any medical condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, or affect clinical or cognitive outcomes, as determined by the Principal Investigator
- Inability to complete study tasks and provide quality data, as determined by the Principal I
Data sourced from ClinicalTrials.gov (NCT03663179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.