Transcranial Magnetic Stimulation + Habit Training for Compulsive Behavior

Overseen By Rebecca Price, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rebecca Price

Must not be taking: Clozapine, Stimulants

Disqualifiers: Epilepsy, Pregnancy, Bipolar, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to address unwanted, repetitive behaviors, known as compulsions, by testing a combination of brain stimulation and habit training. The study employs a non-invasive technique called Transcranial Magnetic Stimulation (TMS) to target specific brain areas, alongside a computer-based habit training program called Habit Override Practice. Multiple groups in the trial receive different combinations of real or sham (placebo) treatments to assess their effects. Ideal participants are adults who have identified problematic compulsive behaviors and can remain in Pittsburgh for at least five weeks. As an unphased trial, this study provides a unique opportunity to contribute to innovative research and potentially benefit from cutting-edge treatment strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on medications that lower the seizure threshold or interfere with TMS. If your medication falls into these categories, you may need to stop or adjust it.

What prior data suggests that Transcranial Magnetic Stimulation and Habit Override Practice are safe for treating compulsive behavior?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe for individuals with conditions like obsessive-compulsive disorder (OCD) and depression. Studies indicate that TMS does not pose major safety concerns for these conditions. The FDA has approved it for treating OCD and other conditions, confirming its safety for use.

For Habit Override Practice, this method also appears safe. It resembles habit reversal training, which has been used for many years to help individuals change unwanted habits. No major safety issues have been reported with this type of training.

Existing evidence indicates that both treatments in the trial are well-tolerated. Participants can feel reassured about the safety of these approaches. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining Transcranial Magnetic Stimulation (TMS) with Habit Override Training for compulsive behavior because this approach targets the brain's neural pathways differently than typical treatments. While most treatments for compulsive behavior, like Cognitive Behavioral Therapy (CBT) and medication, focus on altering thoughts and chemical imbalances, TMS uses magnetic fields to stimulate nerve cells, potentially offering a more direct intervention. The Habit Override Training complements this by actively retraining behavioral patterns, possibly leading to more sustained changes. This dual approach could provide faster and more effective relief for individuals struggling with compulsive behaviors.

What evidence suggests that this trial's treatments could be effective for compulsive behavior?

Research shows that transcranial magnetic stimulation (TMS), one treatment in this trial, may help treat compulsive behaviors. Studies on obsessive-compulsive disorder (OCD) have found that TMS significantly reduces symptoms compared to a placebo. Data supports this by showing that TMS improves scores on the Yale Brown Obsessive Compulsive Scale, which measures OCD severity.

For Habit Override Practice, another treatment option in this trial, evidence from Habit Reversal Therapy (HRT) suggests it helps manage compulsions by increasing awareness and teaching coping skills. Research has shown that these strategies effectively reduce compulsive behaviors, such as those seen in skin-picking disorders. Both treatments in this trial aim to address compulsions by targeting the brain and behavior. ^{1 6 7 8 9}

Who Is on the Research Team?

Rebecca B Price, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with compulsive behaviors, who can stay in Pittsburgh for at least 5 weeks. Participants must be okay with being videotaped during interviews and not have metal implants (except dental fillings), history of brain injury/surgery, or conditions affecting seizure risk like epilepsy.

Inclusion Criteria

Agree to video taping of structured clinical interview

You have reported compulsive behaviors that are concerning to you and have been evaluated by a healthcare professional.

Report that they will reside in the Pittsburgh area for at least 5 weeks

Exclusion Criteria

Failure to meet standard MRI inclusion criteria: those who endorse claustrophobia, those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, implanted uterine devices, metal braces, or other metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results. Pregnancy, determined by pregnancy tests on females.

Medical contraindications for Transcranial Magnetic Stimulation (TMS): Presence of a neurologic disorder or medication therapy known to alter seizure threshold (e.g., stroke, aneurysm, brain surgery, structural brain lesion, brain injury, frequent/severe headaches) Recurrent seizures or epilepsy in participant or family history of hereditary epilepsy Pregnancy Metallic implants in body or other devices that may be affected by magnetic field Significant heart disease or cerebrovascular disease Medications with seizure threshold lowering potential, e.g., clomipramine, Monoamine Oxidase inhibitors (MAOi's), imipramine, clozapine Acute suicidality or other psychiatric crises requiring treatment escalation Changes made to treatment regimen within 4 weeks of baseline assessment Reading level <6th grade Presence of bipolar, psychotic, autism spectrum, or substance use disorder (i.e. current use of mood altering drugs such as cocaine, cannabis or marijuana, opiates, amphetamines, and barbiturates) Presence of movement disorder or tics affecting manual responses Inability to read text from 2 feet away (corrective lenses allowed)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive non-invasive brain stimulation and practice in a computer task to modulate brain activity

1 week

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Habit Override Practice
• Transcranial Magnetic Stimulation

Trial Overview The study tests if brain stimulation (Theta Burst Stimulation) combined with a computer task to practice habit control can influence compulsive behaviors. Some participants will receive real treatment while others get sham (fake) versions to compare effects.

How Is the Trial Designed?

Group I: cTBS + Habit Override Training Experimental Treatment 2 Interventions

Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Habit Override Training.

Group II: Sham TBS + Habit Override Training Active Control 2 Interventions

Sham Transcranial Magnetic Stimulation, paired with Habit Override Training.

Group III: cTBS + Sham Training Active Control 2 Interventions

Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Sham Training.

Group IV: Sham TBS + Sham Training Placebo Group 2 Interventions

Sham Transcranial Magnetic Stimulation, paired with Sham Training.

Who Is Running the Clinical Trial?

Rebecca Price

Lead Sponsor

Trials

8

Recruited

820+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study of 37 OCD patients, those receiving real repetitive transcranial magnetic stimulation (rTMS) showed significant improvement in obsessive-compulsive symptoms compared to those receiving sham treatment, indicating rTMS may be an effective alternative for patients who do not respond well to traditional therapies.

The study identified a specific neural connectivity pattern that predicted symptom improvement, suggesting that rTMS alleviates OCD symptoms by decreasing the connectivity strength of targeted brain networks, highlighting the potential for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-supplementary motor network connectivity and clinical outcome of magnetic stimulation in obsessive-compulsive disorder. Ji, GJ., Xie, W., Yang, T., et al.[2022]

In a randomized sham-controlled study involving 21 medication-resistant OCD patients, 67% of those receiving active rTMS to the supplementary motor area showed a significant response, compared to only 22% in the sham group, indicating the efficacy of rTMS in reducing OCD symptoms.

Patients who underwent 8 weeks of active rTMS experienced a substantial improvement in their OCD symptoms, with scores on the Yale-Brown Obsessive Compulsive Scale decreasing from an average of 28.2 to 14.5, suggesting that rTMS may normalize cortical hyper-excitability associated with OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized sham-controlled trial of repetitive transcranial magnetic stimulation in treatment-resistant obsessive-compulsive disorder. Mantovani, A., Simpson, HB., Fallon, BA., et al.[2021]

A study involving 69 individuals with compulsive behaviors showed that intermittent theta-burst stimulation (iTBS) targeting the left orbitofrontal cortex (OFC) increased resting-state functional connectivity (RSFC) with key brain areas compared to continuous TBS (cTBS).

The enhanced RSFC after iTBS was linked to better engagement of the OFC and correlated with the subjective difficulty experienced during behavioral 'habit override' training, suggesting that iTBS may improve the effectiveness of behavioral interventions for compulsive behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resting-State Functional Connectivity Differences Following Experimental Manipulation of the Orbitofrontal Cortex in Two Directions via Theta-Burst Stimulation. Price, RB., Ferrarelli, F., Hanlon, C., et al.[2023]

Repetitive transcranial magnetic stimulation (rTMS) has shown potential in reducing cravings associated with compulsive behaviors, as evidenced by 10 out of 17 studies reviewed.

In particular, rTMS applied to the left dorsolateral prefrontal cortex may enhance control over compulsive behaviors, with some studies indicating improved decision-making and control despite varying effects on craving levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation to treat substance use disorders and compulsive behavior. Protasio, MI., da Silva, JP., Arias-Carrión, O., et al.[2019]

In a study involving 42 OCD patients, adjunctive high-frequency right prefrontal rTMS did not show significant efficacy in reducing obsessive-compulsive symptoms as measured by the Yale Brown Obsessive Compulsive Scale (YBOCS).

However, the treatment demonstrated modest effectiveness in alleviating comorbid depressive symptoms, as indicated by significant improvements in Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) scores over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive high-frequency right prefrontal repetitive transcranial magnetic stimulation (rTMS) was not effective in obsessive-compulsive disorder but improved secondary depression. Sarkhel, S., Sinha, VK., Praharaj, SK.[2022]

In a double-blind study involving 18 subjects with treatment-resistant OCD, repetitive transcranial magnetic stimulation (rTMS) did not show significant efficacy compared to sham treatment after 10 sessions.

After extending to 20 sessions, rTMS resulted in a significant reduction in OCD symptoms, but this effect was not maintained when accounting for depression, indicating limited effectiveness for OCD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for the treatment of obsessive compulsive disorder: a double-blind controlled investigation. Sachdev, PS., Loo, CK., Mitchell, PB., et al.[2007]

Low-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the supplementary motor area (SMA) showed significant clinical improvement in patients with obsessive-compulsive disorder (OCD) and Tourette's syndrome (TS) after 10 daily sessions.

The treatment not only reduced symptoms as measured by various scales but also normalized hyperexcitability in the right motor cortex, with improvements lasting up to 3 months after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation (rTMS) in the treatment of obsessive-compulsive disorder (OCD) and Tourette's syndrome (TS). Mantovani, A., Lisanby, SH., Pieraccini, F., et al.[2016]

Repetitive transcranial magnetic stimulation (rTMS) shows promise in treating addiction by potentially correcting dysfunctions in the brain's reward system, which are often overlooked in traditional treatments.

The therapy may help reduce cravings by addressing the underlying hedonic dysregulation associated with addiction, suggesting a new avenue for effective interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Light in the Darkness: Repetitive Transcranial Magnetic Stimulation (rTMS) to Treat the Hedonic Dysregulation of Addiction. Pettorruso, M., di Giannantonio, M., De Risio, L., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6491945/

Habit Reversal Therapy in Obsessive Compulsive Related ... Habit Reversal Therapy in OCD​​ The abstract reported the outcome of a 12-session group intervention, which included habit reversal, on symptom ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2773021222000918

Habit reversal training for excoriation disorder: Differential ... First-line psychotherapeutic for ED is habit reversal training (HRT). This intervention is designed develop awareness and skills to better tolerate urges to ...

3. elifesciences.org elifesciences.org/reviewed-preprints/87346

Action-sequence learning, habits and automaticity in ... This study provides solid evidence for differences in habit-learning in obsessive-compulsive disorder versus controls.

4. discoveryaba.com discoveryaba.com/aba-therapy/behavioral-strategies-for-addressing-compulsive-behavior

Behavioral strategies for addressing compulsive behavior This article explores evidence-based behavioral strategies that help individuals identify triggers, resist compulsions, and develop healthier coping mechanisms, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7404378/

Reducing risky behavior with habit reversal - PubMed Central The current paper provides a brief review of HRT for hand‐to‐head habits that is designed for a broad audience and concludes with practical suggestions.

6. webmd.com webmd.com/parenting/what-is-habit-reversal-training

What Is Habit Reversal Training? It's a training or behavioral therapy that helps people reverse or unlearn a bad habit by following certain habit reversal training steps.

7. nature.com nature.com/articles/s41598-022-11971-6

Inhibitory control hinders habit change | Scientific Reports We use a novel experimental design to test how inhibitory control affects two key components of changing (rewiring) habit-like behaviors in healthy humans.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3988923/

Enhanced Avoidance Habits in Obsessive-Compulsive ... These data indicate that OCD patients have a tendency to develop excessive avoidance habits, providing support for a habit account of OCD.

9. researchgate.net researchgate.net/publication/332623980_Habit_Reversal_Therapy_in_Obsessive_Compulsive_Related_Disorders_A_Systematic_Review_of_the_Evidence_and_CONSORT_Evaluation_of_Randomized_Controlled_TrialsData_Sheet_1docx

Habit Reversal Therapy in Obsessive Compulsive Related ... Background: Habit Reversal Therapy (HRT) has long been used in the treatment of Tourette Syndrome and Tic Disorders.