A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Adult ADHD
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Change in Performance on Conners Adult ADHD Rating Scale - Self-Report: Long Version (ADHD Symptoms)
Overview
Brief Summary
This study will test the effects of transcranial magnetic stimulation (TMS) on clinical measures of ADHD symptoms.
Detailed Description
Attention Deficit Hyperactivity Disorder (ADHD) is characterized by symptoms of impulsivity, inattention, and hyperactivity that emerge in childhood and frequently persist into adulthood. These symptoms are accompanied by deficits in cognitive control and risky decision making that can lead to negative psychosocial and health-related outcomes. With advances in the neuroimaging field, researchers are learning where and how self-control over decisions and behaviors is executed in the brain. This work points to the central role of neural activity in the dorsolateral prefrontal cortices (DLPFC) in self-control processes that contribute to healthy choices. Emerging evidence shows that activity in the prefrontal cortices and cognitive control circuits can be modulated using a noninvasive and safe intervention: repetitive TMS. This within-subject proof of concept study will investigate whether 20 sessions of TMS (versus sham stimulation) can enhance executive cognitive function in adults with ADHD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Change in Performance on Conners Adult ADHD Rating Scale - Self-Report: Long Version (ADHD Symptoms)
Time Frame: Baseline and week 4
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.
Secondary Outcomes
- Change in Performance on Conners Continuous Performance Task (Sustained Attention)(Baseline and week 4)