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N/A N=32 Randomized Triple-blind Treatment

Transcranial Magnetic Stimulation for Attention Deficit/Hyperactivity Disorder (ADHD)

Attention Deficit Disorder With Hyperactivity (ADHD)

Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Change in Performance on Conners Adult ADHD Rating Scale - Self-Report: Long Version (ADHD Symptoms) — -4.4; -5.1 t-score

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

OutcomeResultp-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

This study will test the effects of transcranial magnetic stimulation (TMS) on clinical measures of ADHD symptoms.

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
View full record on ClinicalTrials.gov →

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.

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