rTMS for Impulse Control Disorders

(RAPID Trial)

Overseen By Francesco Versace, PHD, PHD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antidepressants, Antipsychotics, Nicotine therapy, others

Disqualifiers: Neurological disorders, Cardiac disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether repetitive transcranial magnetic stimulation (rTMS), which uses magnetic fields to stimulate the brain, can help manage excessive eating. Participants will receive various rTMS treatments to assess their impact on impulse control related to eating. This trial may suit individuals with a body mass index (BMI) over 30 who struggle to manage their eating habits. Participants should be comfortable with both in-person and telehealth sessions and have a stable living situation. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, especially those with psychotropic effects (like antidepressants or antipsychotics) and those that increase the risk of seizures. If you're on any investigational drugs or medications for weight control, you may also need to stop them.

What prior data suggests that rTMS is safe for impulse control disorders?

Previous studies have shown that intermittent theta burst stimulation (iTBS) is generally safe. The FDA has approved it for treating depression, indicating it is well-tolerated. Research in various conditions, such as depression and autism, supports its safety.

For continuous theta burst stimulation (cTBS), reviews suggest it is safe, but experts advise caution due to its newer status. Studies have tested cTBS in various conditions, and it has been generally well-received without major safety concerns.

Overall, research has shown that both iTBS and cTBS are safe, with no serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using repetitive Transcranial Magnetic Stimulation (rTMS) for impulse control disorders because it offers a non-invasive approach that targets specific brain regions associated with impulsive behavior. Most current treatments for impulse control disorders involve behavioral therapy or medications that can take weeks to show effect and may have side effects. rTMS, however, uses magnetic fields to stimulate neurons, potentially providing quicker results without the need for medication. Importantly, the study explores different stimulation patterns, like continuous and intermittent theta burst stimulation, which could offer customized approaches to improve self-control more effectively.

What evidence suggests that rTMS could be an effective treatment for excessive eating?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) might help with impulse control issues, such as overeating. In this trial, participants will receive either intermittent theta burst stimulation (iTBS) or continuous theta burst stimulation (cTBS), both forms of rTMS. Some studies have found iTBS promising in improving brain connections and reducing self-harm. Meanwhile, cTBS has effectively eased symptoms of obsessive-compulsive disorder (OCD) and anxiety. Both iTBS and cTBS target brain areas linked to mood and impulse control. These findings suggest that rTMS could help manage behaviors like overeating by altering brain activity patterns. ^{6 7 8 9 10}

Who Is on the Research Team?

Francesco Versace, PHD,PHD

Principal Investigator

The Unversity of Texas MD Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with impulse control disorders, specifically those who struggle with excessive eating. Participants should meet certain health criteria to be included.

Inclusion Criteria

I agree to attend both online and in-person doctor visits and to be contacted by text.

BMI >30 (confirmed at in-person visit)

Able to follow verbal and written instructions in English and complete all aspects of the study

Exclusion Criteria

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) or any other metal object in the body

I have had seizures, fainting, or head injuries with significant unconsciousness.

I have had weight loss surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo rTMS once a week for 2 weeks, with continuous theta burst stimulation (cTBS) for 3 sessions in week 1 and intermittent theta burst stimulation (iTBS) for 3 sessions in week 2. Additionally, participants complete cued food delivery task assessment and undergo saliva sample collection.

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the incidence of adverse events.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview The study is testing whether accelerated rTMS (repetitive transcranial magnetic stimulation) can help manage excessive eating as an additional treatment option.

How Is the Trial Designed?

Group I: Intermittent theta burst stimulation Experimental Treatment 1 Intervention

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.

Group II: Continuous theta burst stimulation Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) is a powerful tool that can effectively treat clinical depression and potentially other brain disorders, but it carries risks, including the potential to induce seizures, as evidenced by 7 known cases by 1996.

A workshop established safety guidelines for rTMS, emphasizing the importance of monitoring, ethical considerations, and the expertise required for its administration to minimize risks and enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Wassermann, EM.[2022]

Pathological impulsivity is a key feature in neuropsychiatric disorders like ADHD and Borderline Personality Disorder (BPD), contributing to significant distress and morbidity.

Transcranial Magnetic Stimulation (TMS) and repetitive TMS (rTMS) show promise as both investigative and therapeutic tools for addressing impulsivity in these disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Transcranial magnetic stimulation (TMS & rTMS) in investigation and possible treatment of Impulsivity in neuropsychiatric disorders with ADHD and BPD as examples. Zaman, R.[2019]

In a study involving 9 healthy men with pathological gambling, repeated transcranial magnetic stimulation (rTMS) and continuous theta burst stimulation (cTBS) were found to reduce the desire to gamble and the physiological effects associated with gambling, such as diastolic blood pressure.

While neither treatment significantly affected impulsive betting behavior, both increased Stroop interference, suggesting that these interventions may alter cognitive processes related to gambling reinforcement rather than directly changing gambling behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of High Frequency Repeated Transcranial Magnetic Stimulation and Continuous Theta Burst Stimulation on Gambling Reinforcement, Delay Discounting, and Stroop Interference in Men with Pathological Gambling. Zack, M., Cho, SS., Parlee, J., et al.[2019]

In a study of 63 obese individuals undergoing a 5-week rTMS treatment for weight control, the treatment showed a reassuring safety profile with no unexpected adverse events reported up to one year after treatment.

The most common side effects were moderate headaches (40.4%) and local pain/discomfort (19.2%), particularly more frequent in the high-frequency rTMS group, but overall, rTMS was well tolerated in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. Ferrulli, A., Massarini, S., Macrì, C., et al.[2021]

Repetitive Transcranial Magnetic Stimulation (rTMS) has shown promising efficacy in treating various addictions, with strong evidence for nicotine addiction (effective in 218 out of 289 subjects) and moderate evidence for alcohol and cocaine addictions, indicating its potential as a therapeutic tool.

Despite its effectiveness, the current evidence for rTMS in treating other addictions like heroin and methamphetamine is limited, highlighting the need for further research to understand its mechanisms and improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Repetitive Transcranial Magnetic Stimulation (rTMS) in Treatment of Addiction and Related Disorders: A Systematic Review. Makani, R., Pradhan, B., Shah, U., et al.[2018]

Repetitive Transcranial Magnetic Stimulation (rTMS) has a good overall safety profile for treating depression, with common side effects like headaches being minor and manageable.

While there is a low incidence of serious side effects such as seizures and hypomania, these are linked to specific risk factors, suggesting that proper screening can enhance patient safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. Loo, CK., McFarquhar, TF., Mitchell, PB.[2021]

Repetitive transcranial magnetic stimulation (rTMS) has been shown to have a small but significant effect on reducing motor impulsivity and a moderate effect on reducing temporal impulsivity in healthy adults, based on a systematic review and meta-analysis of multiple studies.

The study highlights the need for further research to explore the potential of rTMS in modulating impulsivity in at-risk populations, such as individuals with histories of self-harm or offending behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of rTMS on Impulsivity in Normal Adults: a Systematic Review and Meta-Analysis. Yang, CC., Völlm, B., Khalifa, N.[2019]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

Repetitive transcranial magnetic stimulation (TMS) has shown significant efficacy in reducing cravings for substance addiction, particularly when targeting the right dorsolateral prefrontal cortex (DLPFC), based on a meta-analysis of eight randomized controlled trials involving 199 patients.

Active TMS stimulation was found to be superior to sham treatments, with a notable effect size (Hedge's g = 1.48), suggesting that this specific TMS protocol could be a promising therapeutic tool in addiction treatment, despite limitations such as small study numbers and high heterogeneity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing an effective TMS protocol for craving in substance addiction: Is it possible? Enokibara, M., Trevizol, A., Shiozawa, P., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) shows promise as a treatment for substance use disorders, including alcohol and nicotine dependence, based on various studies reviewed in this paper.

The review highlights the need for more clinical data to better understand the mechanisms of action of rTMS in treating these disorders and to establish its efficacy in broader applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation (rTMS) in the Management of Alcohol Dependence and other Substance Abuse Disorders - Emerging Data and Clinical Relevance. Sousa, AD.[2020]

A review of 18 clinical trials found that repetitive transcranial magnetic stimulation (rTMS) is effective in reducing cravings associated with various addictions, particularly in the short term.

Most studies used a Visual Analogue Scale to measure craving, highlighting the need for standardized assessment methods to improve the reliability of rTMS efficacy results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of repetitive transcranial magnetic stimulation for modulating craving and addictive behaviours: a critical literature review of efficacy, technical and methodological considerations. Grall-Bronnec, M., Sauvaget, A.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12000664/

A Case Series on the Effect of Continuous Theta Burst ... This study included patients with OCD receiving continuous theta burst stimulation over the supplementary motor area attending a tertiary care centre.

2. nature.com nature.com/articles/s41386-019-0584-4

One-year clinical outcomes following theta burst ... Theta burst transcranial magnetic stimulation (TBS) is a potential new treatment for post-traumatic stress disorder (PTSD).

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006322323017882

Comparisons of Accelerated Continuous and Intermittent ... Accelerated cTBS was superior to iTBS in the management of suicidal ideation (pweek 1 = .027) and anxiety symptoms (pweek 1 = .01). Accelerated ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04696471

Effects of Theta Burst Stimulation on the Brain, Behavior ... Bipolar Disorder (BD) is a common and highly debilitating psychiatric disorder, however, the predisposing brain mechanisms are poorly understood.

5. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.042924

Continuous Theta-Burst Stimulation of the Contralesional ... Ten daily sessions of cTBS of the contralesional primary motor cortex combined with upper limb training, started within 3 weeks after stroke onset, promote ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8617062/

A Systematic Review of the Safety and Tolerability of Theta ... In 2018 the FDA cleared intermittent theta burst stimulation (iTBS) delivered to the left dorsolateral prefrontal cortex for the treatment of major depressive ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3260517/

Safety of Theta Burst Transcranial Magnetic Stimulation Based on this review, TBS appears to be a safe and efficacious technique. However, given its novelty, it should be applied with caution.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06314139

Tolerability and Efficacy of Continuous Theta-burst ... Therefore, the investigators conducted a double-blind, randomized, sham-controlled clinical trial to evaluate the safety and efficacy of cTBS in ...

9. nature.com nature.com/articles/s41398-024-03041-4

Continuous theta burst stimulation to relieve symptoms in ... This is the first study with an external validation design across two centers to identify OCD symptoms as playing an important role in cTBS treatment effects.

10. sciencedirect.com sciencedirect.com/science/article/pii/S2589004221015844

Continuous theta-burst stimulation over the right ... These findings demonstrate that cTBS time-dependently and delay-dependently prevents the return of fear and may have clinical potential for treating fear- ...