NCT03663179

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

A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Adult ADHD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Disorder With Hyperactivity (ADHD)

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation (TMS)	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).
DEVICE	Sham Transcranial Magnetic Stimulation (Sham TMS)	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).

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-03-31
• Completion: 2020-01-01
• First posted: 2018-09-10
• Last updated: 2022-08-05
• Results posted: 2019-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study