Executive DysfunctionTPDNCT04074811
Feasibility and Efficacy of rTMS in Healthy Persons
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Executive Dysfunction and Pain, run by Wayne State University at 1 site in United States.
Trial summary
Transcranial magnetic stimulation (TMS) is a neuromodulation device that is FDA-approved for use in treating depression and obsessive compulsive disorder. TMS works by applying a safe, electromagnetic field on the scalp, which can either increase or decrease neuronal communication and activity (depending on the mode… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Dysfunction, Pain, Mood
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 10 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Right handed
- 21-60 years of age
- IQ score greater than 80
- Eligible if using tobacco, alcohol, or marijuana fewer than 3 times per week; each "time" must be less than 3 cigarettes or drinks, or less than 1 marijuana "joint"
Who cannot join
- Under influence of any substances during any session
- Use of illicit substances in the past 30 days
- Pregnant
- Medical conditions that prohibit the use of rTMS (e.g. history of seizures or medications that lower seizure threshold)
- Current DSM-5 Axis I psychiatric disorders, or any history of substance use disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Feasibility and Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in a Healthy Population
Transcranial magnetic stimulation (TMS) is a neuromodulation device that is FDA-approved for use in treating depression and obsessive compulsive disorder. TMS works by applying a safe, electromagnetic field on the scalp, which can either increase or decrease neuronal communication and activity (depending on the mode of stimulation). Although it is only approved for two disorders, there has been substantial research into the potential of TMS to treat a wide range of neuropsychiatric disorders, including substance use disorders (SUDs). This project aims to develop an initial TMS protocol in a sample of healthy controls and to establish the feasibility and efficacy of using repetitive TMS (rTMS) to impact several carefully-selected cognitive, behavioral, and physiologic measures. This pilot project will enable the research team to gather baseline data using this new method and to plan longer-term programmatic studies focusing on populations with SUDs. The overarching aim of this project is to develop an rTMS protocol for use in the human laboratory setting with both healthy controls and individuals with SUDs. The investigators also hope to learn about the impact of high frequency rTMS over the DLPFC on multiple aspects of functioning including: cognitive control, impulsivity, thermal pain sensitivity, motivation, and mood.
Read the detailed description
The short-term goal of this pilot project is to establish the feasibility and efficacy of repetitive transcranial magnetic stimulation (rTMS) on cognitive, behavioral, and physiological measures in a healthy community-recruited sample to plan longer-term programmatic studies focusing on substance use disorder (SUD) populations. Primary Aims are to examine the effect of one session of left dorsolateral prefrontal cortex (DLPFC) rTMS high-frequency (10 Hz) stimulation vs. placebo stimulation (no electromagnetic field but similar auditory and tactile sensations) on: (1) cognitive control, (2), impulsivity, and (3) thermal pain sensitivity. Secondary Aims are to test effects of rTMS on behavioral motivation (monetary incentive delay task, effort choice task), mood (PANAS), peripheral biomarkers (prolactin, BDNF) and collect biosamples for future genotyping.
The investigators recognize the proposed sample size is relatively small to adequately power a full analysis across all outcomes, so will use this study to determine effect sizes for any differences to plan future studies with adequate power. Generally speaking, data will be analyzed using repeated measures ANCOVAs; covariates will include TMS resting motor threshold, sex, and age. Based on sample size calculations, the investigators intend to complete up to 30 subjects. For some outcomes, the results of previous studies indicate that a lower sample size may be appropriate, therefore the investigators will conduct interim analyses at n=18 to calculate effect sizes to determine how many more participants are needed.
- Conditions
- Executive Dysfunction, Pain, Mood
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
The investigators will use the Figure of 8 coil, which affects ~10cm2 of cortical surface. The active condition will deliver stimulation at 110% of resting motor threshold (RMT). To determine RMT, the protocol will be: 10 trials of single-pulse TMS on the scalp position of the abductor pollicis brevis muscle (which controls thumb flexion); RMT is the lowest TMS power setting yielding visible motor contraction on >50% of trials.
| Study group | Role | What they receive |
|---|---|---|
| Sham rTMS | Sham comparator | Sham rTMS will be applied over the left dorsolateral prefrontal cortex using a sham figure of 8 coil (within-subject crossover). Sham rTMS will consist of the same auditory and tactile stimuli as the active condition, but does not induce an electromagnetic field and does not affect cortical excitability. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Active rTMS | Active comparator | Active rTMS will be applied over the left dorsolateral prefrontal cortex using an active figure of 8 coil (within-subject crossover). In the active rTMS condition, the investigators will use high-frequency (10Hz) dorsolateral prefrontal cortex (dlPFC) stimulation with intensity of 110% of resting motor threshold. rTMS will consist of 120 trains with 50 stimuli per train (i.e. 5-sec long at 10 Hz) and 10-sec intertrain interval for a total of 6000 pulses. The entire protocol will last 30 min (120 trains with 5-sec on/10-sec off). Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop Task (cognitive control)
Examine the effect of rTMS stimulation on cognitive control as measured by the Stroop Color-Word task.
Measured: Change from pre- to 25-minutes post-rTMS stimulation in each session
Stop Signal Task (impulsivity)
Examine the effect of rTMS stimulation on impulsivity as measured by the Stop Signal Task.
Measured: Change from pre- to 15-minutes post-rTMS stimulation in each session
Pain Sensitivity
Examine the effect of rTMS stimulation on pain sensitivity as measured by thermal quantitative sensory threshold (QST) testing.
Measured: Change from pre- to 50-minutes post-rTMS stimulation in each session
Delay Discounting Task (cognitive control)
Examine the effect of rTMS stimulation on cognitive control as measured by the brief (2-min) monetary delay discounting task
Measured: Change from pre- to 10-minutes post-rTMS stimulation in each session
Secondary outcomes (4)
Effort Choice Task (motivation)
Examine the effect of rTMS stimulation on behavioral responding as measured by the Effort Choice Task (number of responses on progressive ratio vs. fixed ratio schedules of reinforcement).
Measured: Change from pre- to 30-minutes post-rTMS stimulation in each session
Mood
Examine the effect of rTMS stimulation on mood state as measured by the Positive and Negative Affect Schedule.
Measured: Change from pre- to 5-minutes post-rTMS stimulation in each session
Peripheral Biomarkers
Examine the effect of rTMS stimulation on peripheral biomarkers as measured by the plasma concentrations (ng/ml) of brain derived neurotrophic factor (BDNF) and prolactin.
Measured: Change from pre- to 0-minutes post-rTMS stimulation in each session
Monetary Incentive Delay Task (motivation)
Examine the effect of rTMS stimulation on behavioral responding as measured by the Monetary Incentive Delay Task
Measured: Change from pre- to 40-minutes post-rTMS stimulation in each session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start10 Apr 2023
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive DysfunctionStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This pilot study will use a single-blind, left dorsolateral prefrontal cortex (10-Hz) vs. sham, 2-session, within-subjects randomized crossover design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Greenwald, PhD, Wayne State University
- Investigators
- Mark K Greenwald, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074811
- Sponsor's protocol ID
- TPD-1
- Acronym
- TPD
- Status last verified
- Apr 2023
- First submitted
- 20 Aug 2019
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The research team is committed to disclosing and sharing scientific findings as outlined by NIH policy guidance on Sharing Research Data and on Sharing Model Organisms (see: http://grants.nih.gov/grants/policy/data\_sharing/data\_sharing\_guidance.htm#time). We note that, "NIH recognizes that the investigators who collected the data have a legitimate interest in benefiting from their investment of time and effort. NIH continues to expect that the initial investigators may benefit from first and continuing use but not from prolonged exclusive use." The research team (PI, with advice from co-investigators) plans to share data from this project as follows. We will disseminate data using conventional means including published abstracts, conference presentations (posters and talks), news releases, and peer reviewed journal articles.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility and Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in a Healthy Population
- ClinicalTrials.gov ID
- NCT04074811
- Acronym / sponsor ID
- TPD / TPD-1
- Conditions
- Executive Dysfunction, Pain, Mood
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcranial magnetic stimulation (TMS) is a neuromodulation device that is FDA-approved for use in treating depression and obsessive compulsive disorder. TMS works by applying a safe, electromagnetic field on the scalp, which can either increase or decrease neuronal communication and activity (depending on the mode of stimulation). Although it is only approved for two disorders, there has been substantial research into the potential of TMS to treat a wide range of neuropsychiatric disorders, including substance use disorders (SUDs). This project aims to develop an initial TMS protocol in a sample of healthy controls and to establish the feasibility and efficacy of using repetitive TMS (rTMS) to impact several carefully-selected cognitive, behavioral, and physiologic measures. This pilot project will enable the research team to gather baseline data using this new method and to plan longer-term programmatic studies focusing on populations with SUDs. The overarching aim of this project is to develop an rTMS protocol for use in the human laboratory setting with both healthy controls and individuals with SUDs. The investigators also hope to learn about the impact of high frequency rTMS over the DLPFC on multiple aspects of functioning including: cognitive control, impulsivity, thermal pain sensitivity, motivation, and mood.
Detailed description
The short-term goal of this pilot project is to establish the feasibility and efficacy of repetitive transcranial magnetic stimulation (rTMS) on cognitive, behavioral, and physiological measures in a healthy community-recruited sample to plan longer-term programmatic studies focusing on substance use disorder (SUD) populations. Primary Aims are to examine the effect of one session of left dorsolateral prefrontal cortex (DLPFC) rTMS high-frequency (10 Hz) stimulation vs. placebo stimulation (no electromagnetic field but similar auditory and tactile sensations) on: (1) cognitive control, (2), impulsivity, and (3) thermal pain sensitivity. Secondary Aims are to test effects of rTMS on behavioral motivation (monetary incentive delay task, effort choice task), mood (PANAS), peripheral biomarkers (prolactin, BDNF) and collect biosamples for future genotyping.
The investigators recognize the proposed sample size is relatively small to adequately power a full analysis across all outcomes, so will use this study to determine effect sizes for any differences to plan future studies with adequate power. Generally speaking, data will be analyzed using repeated measures ANCOVAs; covariates will include TMS resting motor threshold, sex, and age. Based on sample size calculations, the investigators intend to complete up to 30 subjects. For some outcomes, the results of previous studies indicate that a lower sample size may be appropriate, therefore the investigators will conduct interim analyses at n=18 to calculate effect sizes to determine how many more participants are needed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This pilot study will use a single-blind, left dorsolateral prefrontal cortex (10-Hz) vs. sham, 2-session, within-subjects randomized crossover design.
| Arm | Type | Receives |
|---|---|---|
| Sham rTMS | Sham comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Sham rTMS will be applied over the left dorsolateral prefrontal cortex using a sham figure of 8 coil (within-subject crossover). Sham rTMS will consist of the same auditory and tactile stimuli as the active condition, but does not induce an electromagnetic field and does not affect cortical excitability. |
| Active rTMS | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Active rTMS will be applied over the left dorsolateral prefrontal cortex using an active figure of 8 coil (within-subject crossover). In the active rTMS condition, the investigators will use high-frequency (10Hz) dorsolateral prefrontal cortex (dlPFC) stimulation with intensity of 110% of resting motor threshold. rTMS will consist of 120 trains with 50 stimuli per train (i.e. 5-sec long at 10 Hz) and 10-sec intertrain interval for a total of 6000 pulses. The entire protocol will last 30 min (120 trains with 5-sec on/10-sec off). |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy
- Right handed
- 21-60 years of age
- IQ score greater than 80
- Eligible if using tobacco, alcohol, or marijuana fewer than 3 times per week; each "time" must be less than 3 cigarettes or drinks, or less than 1 marijuana "joint"
Key exclusion criteria (5 listed)
- Under influence of any substances during any session
- Use of illicit substances in the past 30 days
- Pregnant
- Medical conditions that prohibit the use of rTMS (e.g. history of seizures or medications that lower seizure threshold)
- Current DSM-5 Axis I psychiatric disorders, or any history of substance use disorders.
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)The investigators will use the Figure of 8 coil, which affects ~10cm2 of cortical surface. The active condition will deliver stimulation at 110% of resting motor threshold (RMT). To determine RMT, the protocol will be: 10 trials of single-pulse TMS on the scalp position of the abductor pollicis brevis muscle (which controls thumb flexion); RMT is the lowest TMS power setting yielding visible motor contraction on >50% of trials. | Device | Active rTMS, Sham rTMS |
Primary outcome
Stroop Task (cognitive control)
Time frame: Change from pre- to 25-minutes post-rTMS stimulation in each session
Examine the effect of rTMS stimulation on cognitive control as measured by the Stroop Color-Word task.
Stop Signal Task (impulsivity)
Time frame: Change from pre- to 15-minutes post-rTMS stimulation in each session
Examine the effect of rTMS stimulation on impulsivity as measured by the Stop Signal Task.
Pain Sensitivity
Time frame: Change from pre- to 50-minutes post-rTMS stimulation in each session
Examine the effect of rTMS stimulation on pain sensitivity as measured by thermal quantitative sensory threshold (QST) testing.
Delay Discounting Task (cognitive control)
Time frame: Change from pre- to 10-minutes post-rTMS stimulation in each session
Examine the effect of rTMS stimulation on cognitive control as measured by the brief (2-min) monetary delay discounting task
4 secondary outcomes
Effort Choice Task (motivation)
Time frame: Change from pre- to 30-minutes post-rTMS stimulation in each session
Mood
Time frame: Change from pre- to 5-minutes post-rTMS stimulation in each session
Peripheral Biomarkers
Time frame: Change from pre- to 0-minutes post-rTMS stimulation in each session
Monetary Incentive Delay Task (motivation)
Time frame: Change from pre- to 40-minutes post-rTMS stimulation in each session
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: Yes. The research team is committed to disclosing and sharing scientific findings as outlined by NIH policy guidance on Sharing Research Data and on Sharing Model Organisms (see: http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm#time). We note that, "NIH recognizes that the investigators who collected the data have a legitimate interest in benefiting from their investment of time and effort. NIH continues to expect that the initial investigators may benefit from first and continuing use but not from prolonged exclusive use." The research team (PI, with advice from co-investigators) plans to share data from this project as follows. We will disseminate data using conventional means including published abstracts, conference presentations (posters and talks), news releases, and peer reviewed journal articles.
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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.
Mark K Greenwald, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Executive Dysfunction and Pain, run by Wayne State University 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 5 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: withdrawn, as of the sponsor's last update on 13 Apr 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Stroop Task (cognitive control) (time frame: Change from pre- to 25-minutes post-rTMS stimulation in each session). The study lists 4 primary outcomes in all. 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 13 Apr 2023.