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

NCT03663179 | Completed Results FDA Device

• 1 other identifier: 826586
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD)

Keywords

ADHD; TMS

Outcome Measures

Primary Outcomes (1)

• Change in Performance on Conners Adult ADHD Rating Scale - Self-Report: Long Version (ADHD Symptoms)

  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.

  Baseline and week 4

Secondary Outcomes (1)

• Change in Performance on Conners Continuous Performance Task (Sustained Attention)

  Baseline and week 4

Study Arms (2)

Active TMS

EXPERIMENTAL

Participants will receive 20 sessions of active TMS targeting the left DLPFC.

Device: Transcranial Magnetic Stimulation (TMS)

Sham TMS

SHAM COMPARATOR

Participants will receive 20 sessions of sham TMS over the left DLPFC.

Device: Sham Transcranial Magnetic Stimulation (Sham TMS)

Interventions

Transcranial Magnetic Stimulation (TMS) DEVICE

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).

Active TMS

Sham Transcranial Magnetic Stimulation (Sham TMS) DEVICE

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).

Sham TMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Leah Bernardo
• Organization: University of Pennsylvania

lleah@pennmedicine.upenn.edu

2157467162

Study Officials

• James Loughead, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: September 10, 2018
• Study Start: January 1, 2017
• Primary Completion: March 31, 2019
• Study Completion: January 1, 2020
• Last Updated: August 5, 2022
• Results First Posted: October 28, 2019

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)