Impulse Control DisorderPhase 1RAPIDNCT06639594
Feasibility of Accelerated, Personalized rTMS as an Adjuvant for Impulse Control Disorders: a Pilot Study
A Phase 1 study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Impulse Control Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if accelerated rTMS (repetitive transcranial magnetic stimulation) can be used as a possible therapy for excessive eating. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Impulse Control Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2024to 3 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Age 21 to 60
- BMI>30 (confirmed at in person visit)
- Able to follow verbal and written instructions in English and complete all aspects of the study.
- Have an address and telephone number where they may be reached.
- Subjects must report current stable residence. Stable residence is a domicile in which an individual can operate as if it were their own homestead and does not include shelters, halfway houses, treatment centers, or group homes.
- Meet safety criteria for EEG and rTMS.
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- Willing and able to independently remove any metal from the neck and above for rTMS procedures (e.g., jewelry, retainer)
- Provides written informed consent and agree to all assessments and study procedures.
- Agrees to complete telehealth (live audio-video conference and phone) and in-person visits and to be contacted via text.
Who cannot join
- rTMS exposure for treatment or research purposes in the last 6 months.
- History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.
- Presence or history of neurological disorders (migraine, stroke, Alzheimer's Disease and other Dementias, Parkinson's Disease, Multiple Sclerosis, Traumatic Brain Injury (TBI), increased intracranial pressure).
- History of brain surgery, implanted electronic device, metal in the head.
- Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes)
- History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.
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- Reported history of vision problems that are not treated.
- Has a hairstyle not compatible with the EEG net that is required to be worn on the scalp during the experimental procedure.
- Reports current diagnosis or history of type I diabetes.
- Currently using insulin.
- Have undergone bariatric surgery.
- Currently being enrolled in a weight loss program
- Takes any prescription or over the counter medications or supplements to control weight and/or appetite.
- Self-report a history of or current diagnosis of a mental health condition.
- Reports insomnia (<4 hours sleep per night, in 3 or more nights per week in the last 3 months)
- Reports (<4 hours of sleep) the day of the visit.
- Reports using marijuana on a daily basis.
- Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months.
- Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).
- Females who report averaging more than 7 alcoholic drinks, or males who report averaging more than 14 alcoholic drinks in a single week in the last 30 days.
- Current use of certain medications (last 3 months):
- Investigational drugs.
- Drugs of anti or pro-convulsive action. Medications with psychotropic effects (e.g., antidepressants, antipsychotics).
- Medications known to increase risk of seizure taken within 1 week of enrollment.
- Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix).
- Being pregnant or lactating
- Reported allergies to chocolate or any ingredient in the M\&M candies.
- Noise-induced hearing loss or tinnitus.
- Currently participating in any other research study.
- Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician
- Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Francesco Versace, PHD,PHD, 713-745-7933, fversace@mdanderson.org
Francesco Versace, PHD,PHD
About this study
To learn if accelerated rTMS (repetitive transcranial magnetic stimulation) can be used as a possible therapy for excessive eating.
Read the detailed description
Primary Objectives:
To evaluate the feasibility of using accelerated rTMS as a potential treatment adjuvant, we will assess the following feasibility primary outcomes:
- Recruitment: We will define recruitment as the probability of an eligible patient consenting to participate in the study. We will deem recruitment for this trial feasible if at least 70% of eligible patients consent to participate in the trial. (i.e., considering a pool of 30 eligible subjects, we consent at least 21 participants).
- Tolerability: For each sequence, we will follow an up-titration procedure (from 80% up to 110% of the motor threshold) and define the optimally tolerable dose (OTD) as the dose that at least 70% of participants can tolerate. Tolerability will be computed separately for each rTMS sequence.
- Safety: To consider the treatment safe, there must be no serious adverse events attributable to rTMS.
Secondary Objectives
We will measure:
- To measure the time required to the staff to conduct each ERP assessment.
- To measure the time between the end of the last rTMS session and the start of the second ERP assessment. We will analyze each measure to obtain an accurate estimate of the duration of each step in the procedures. Our ultimate goal is to develop image-guided, personalized rTMS interventions. Carefully assessing the time required for each step in the protocol will allow us to identify opportunities to further optimize our procedures and reduce the duration of future visits.
- We will conduct exploratory analyses on the amplitude of the late positive potential (LPP) component of the ERPs. Our exploratory analyses will allow us to estimate the LPP responses collected from the "cued food delivery task" before and after the rTMS intervention and assess the level of noise in the data by computing the standardized measurement error (SME).
- Conditions
- Impulse Control Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Medical subject headings
- Disruptive, Impulse Control, and Conduct Disorders
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
RTMS is a non-invasive procedure in which a coil is placed over the scalp, and powerful, focused magnetic pulses are applied to parts of the brain through the coil.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent theta burst stimulation | Experimental | Participants undergo rTMS once a week for 2 weeks. In week 1 participants receive intermittent theta burst stimulation (iTBS)" for 3 sessions; in week 2 participants receive continuous theta burst stimulation ciTBS) for 3 sessions. Additionally, participants complete cued food delivery task assessment and undergo saliva sample collection on study. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Continuous theta burst stimulation | Experimental | Participants undergo rTMS once a week for 2 weeks. In week 1 participants receive continuous theta burst stimulation (cTBS) for 3 sessions; in week 2 participants receive intermittent theta burst stimulation (iTBS) for 3 sessions. Additionally, participants complete cued food delivery task assessment and undergo saliva sample collection on study. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start21 Nov 2024
- Primary completion3 Nov 2027 (estimated)
- Study completion3 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impulse Control DisorderStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Versace, PHD,PHD, Principal investigator, The Unversity of Texas MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639594
- Sponsor's protocol ID
- 2024-0261
- Other IDs
- NCI-2024-08561
- Acronym
- RAPID
- Status last verified
- Sep 2026
- First submitted
- 10 Oct 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Accelerated, Personalized rTMS as an Adjuvant for Impulse Control Disorders: a Pilot Study
- ClinicalTrials.gov ID
- NCT06639594
- Acronym / sponsor ID
- RAPID / 2024-0261
- Conditions
- Impulse Control Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 3 Nov 2027 (estimated)
- Study completion
- 3 Nov 2027 (estimated)
- First posted
- 15 Oct 2024 (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.
To learn if accelerated rTMS (repetitive transcranial magnetic stimulation) can be used as a possible therapy for excessive eating.
Detailed description
Primary Objectives:
To evaluate the feasibility of using accelerated rTMS as a potential treatment adjuvant, we will assess the following feasibility primary outcomes:
- Recruitment: We will define recruitment as the probability of an eligible patient consenting to participate in the study. We will deem recruitment for this trial feasible if at least 70% of eligible patients consent to participate in the trial. (i.e., considering a pool of 30 eligible subjects, we consent at least 21 participants).
- Tolerability: For each sequence, we will follow an up-titration procedure (from 80% up to 110% of the motor threshold) and define the optimally tolerable dose (OTD) as the dose that at least 70% of participants can tolerate. Tolerability will be computed separately for each rTMS sequence.
- Safety: To consider the treatment safe, there must be no serious adverse events attributable to rTMS.
Secondary Objectives
We will measure:
- To measure the time required to the staff to conduct each ERP assessment.
- To measure the time between the end of the last rTMS session and the start of the second ERP assessment. We will analyze each measure to obtain an accurate estimate of the duration of each step in the procedures. Our ultimate goal is to develop image-guided, personalized rTMS interventions. Carefully assessing the time required for each step in the protocol will allow us to identify opportunities to further optimize our procedures and reduce the duration of future visits.
- We will conduct exploratory analyses on the amplitude of the late positive potential (LPP) component of the ERPs. Our exploratory analyses will allow us to estimate the LPP responses collected from the "cued food delivery task" before and after the rTMS intervention and assess the level of noise in the data by computing the standardized measurement error (SME).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent theta burst stimulation | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Participants undergo rTMS once a week for 2 weeks. In week 1 participants receive intermittent theta burst stimulation (iTBS)" for 3 sessions; in week 2 participants receive continuous theta burst stimulation ciTBS) for 3 sessions. Additionally, participants complete cued food delivery task assessment and undergo saliva sample collection on study. |
| Continuous theta burst stimulation | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Participants undergo rTMS once a week for 2 weeks. In week 1 participants receive continuous theta burst stimulation (cTBS) for 3 sessions; in week 2 participants receive intermittent theta burst stimulation (iTBS) for 3 sessions. Additionally, participants complete cued food delivery task assessment and undergo saliva sample collection on study. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 21 to 60
- BMI>30 (confirmed at in person visit)
- Able to follow verbal and written instructions in English and complete all aspects of the study.
- Have an address and telephone number where they may be reached.
- Subjects must report current stable residence. Stable residence is a domicile in which an individual can operate as if it were their own homestead and does not include shelters, halfway houses, treatment centers, or group homes.
Key exclusion criteria (31 listed)
- rTMS exposure for treatment or research purposes in the last 6 months.
- History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.
- Presence or history of neurological disorders (migraine, stroke, Alzheimer's Disease and other Dementias, Parkinson's Disease, Multiple Sclerosis, Traumatic Brain Injury (TBI), increased intracranial pressure).
- History of brain surgery, implanted electronic device, metal in the head.
- Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes)
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)RTMS is a non-invasive procedure in which a coil is placed over the scalp, and powerful, focused magnetic pulses are applied to parts of the brain through the coil. | Device | Continuous theta burst stimulation, Intermittent theta burst stimulation |
Primary outcome
Safety and Adverse Events (AEs).
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Francesco Versace, PHD,PHD principal investigator
The Unversity of Texas MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Impulse Control Disorder, run by M.D. Anderson Cancer Center 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 9 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Versace, PHD, PHD ((713) 745-7933, fversace@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs). (time frame: Through study completion; an average of 1 year.). 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 18 Sep 2026.