- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03663179
Transcranial Magnetic Stimulation for Attention Deficit/Hyperactivity Disorder (ADHD)
A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Adult ADHD
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Investigator
- Low or borderline intellectual functioning - determined by a score of less than 90 on the Shipley Institute of Living Scale (SILS) (administered at Intake Visit). The SILS correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated Intelligence Quotient (IQ) Test
- Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Active TMS
Participants will receive 20 sessions of active TMS targeting the left DLPFC.
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A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS.
This coil has an active side and a sham side, and can be used to perform double-blinded studies.
TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold.
Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval).
Subjects will receive 80 trains per session for a total of 4000 pulses per session (~26 min sessions).
Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
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Sham Comparator: Sham TMS
Participants will receive 20 sessions of sham TMS over the left DLPFC.
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A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS.
This coil has an active side and a sham side, and can be used to perform double-blinded studies.
For sham stimulation, the sham side of the coil is positioned toward the participant's scalp.
The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%.
This reduction in field strength ensures that no neural stimulation occurs.
Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Performance on Conners Adult ADHD Rating Scale - Self-Report: Long Version (ADHD Symptoms)
Time Frame: Baseline and week 4
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ADHD symptoms will be assessed using the well-validated Conners Adult ADHD Rating Scale - Self-Report: Long Version (CAARS-S:L).
The CAARS-S:L is a 66-item rating scale designed to assess ADHD symptoms in adults.
The scale contains multiple subscales to assess Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) specified ADHD criteria as well as other facets of ADHD such as inattention/memory problems, hyperactivity/restlessness, impulsivity/emotionality, and problems with self-concept.
Subscale results are converted to T-scores (range: 25-90), where 50 is the standardized population mean and every 10 points indicates one standard deviation from the mean.
Higher values generally indicate more difficulties with ADHD symptoms.
This measure will be administered at baseline at at the end of 4 weeks of treatment.
The primary outcome will be the change from baseline to week 4.
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Baseline and week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Performance on Conners Continuous Performance Task (Sustained Attention)
Time Frame: Baseline and week 4
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The Conners Continuous Performance Task (Conners CPT) will be administered and baseline and weekly during the treatment period to assess sustained attention.
In this task, participants are shown a series of letters on a computer screen and are asked to press the spacebar in response to all letters except for the letter X.
The primary outcome for the Conners CPT is the change in number of commission errors (e.g., false positives) from baseline to week 4.
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Baseline and week 4
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Loughead, PhD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 826586
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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