Transcranial Magnetic Stimulation for Attention Deficit/Hyperactivity Disorder (ADHD)
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|ClinicalTrials.gov Identifier: NCT03663179|
Recruitment Status : Active, not recruiting
First Posted : September 10, 2018
Results First Posted : October 28, 2019
Last Update Posted : October 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder With Hyperactivity (ADHD)||Device: Transcranial Magnetic Stimulation (TMS) Device: Sham Transcranial Magnetic Stimulation (Sham TMS)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Adult ADHD|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Active TMS
Participants will receive 20 sessions of active TMS targeting the left DLPFC.
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).
Sham Comparator: Sham TMS
Participants will receive 20 sessions of sham TMS over the left DLPFC.
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).
- 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.
- Change in Performance on Conners Continuous Performance Task (Sustained Attention) [ Time Frame: Baseline and week 4 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663179
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||James Loughead, PhD||University of Pennsylvania|