Attention Deficit Disorder With Hyperactivity (ADHD)NCT03663179
Transcranial Magnetic Stimulation for Attention Deficit/Hyperactivity Disorder (ADHD)
A study testing Transcranial Magnetic Stimulation (TMS) in people with Attention Deficit Disorder With Hyperactivity (ADHD), run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will test the effects of transcranial magnetic stimulation (TMS) on clinical measures of ADHD symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity (ADHD)
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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:
Show all 43Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Adult ADHD
This study will test the effects of transcranial magnetic stimulation (TMS) on clinical measures of ADHD symptoms.
Read the 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.
- Being tested
- Transcranial Magnetic Stimulation (TMS), Sham Transcranial Magnetic Stimulation (Sham TMS)
- Keywords
- ADHD, TMS
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| Active TMS | Experimental | Participants will receive 20 sessions of active TMS targeting the left DLPFC. Receives: Device: Transcranial Magnetic Stimulation (TMS) |
| Sham TMS | Sham comparator | Participants will receive 20 sessions of sham TMS over the left DLPFC. Receives: Device: Sham Transcranial Magnetic Stimulation (Sham TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 4
Secondary outcomes (1)
Change in Performance on Conners Continuous Performance Task (Sustained Attention)
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.
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study startJan 2017
- Primary completion31 Mar 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Disorder With Hyperactivity (ADHD)Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Loughead, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663179
- Sponsor's protocol ID
- 826586
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2018
- Last updated
- 5 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Adult ADHD
- ClinicalTrials.gov ID
- NCT03663179
- Acronym / sponsor ID
- 826586
- Keywords
- ADHD, TMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Posted 28 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TMS | Experimental | Device: Transcranial Magnetic Stimulation (TMS)Participants will receive 20 sessions of active TMS targeting the left DLPFC. |
| Sham TMS | Sham comparator | Device: Sham Transcranial Magnetic Stimulation (Sham TMS)Participants will receive 20 sessions of sham TMS over the left DLPFC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (43 listed)
- 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:
- 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.
- Current use or recent discontinuation (within the past 6 months at the time of Intake) of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Active TMS |
| 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). | Device | Sham TMS |
Primary outcome
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.
1 secondary outcome
Change in Performance on Conners Continuous Performance Task (Sustained Attention)
Time frame: Baseline and week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Loughead, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Attention Deficit Disorder With Hyperactivity (ADHD), run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Performance on Conners Adult ADHD Rating Scale - Self-Report: Long Version (ADHD Symptoms) (time frame: Baseline and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.