Transcranial Magnetic Stimulation + Habit Training for Compulsive Behavior

Recruiting in Palo Alto (17 mi)

Overseen by Rebecca B Price, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rebecca Price

Must not be taking: Clozapine, Stimulants

Disqualifiers: Epilepsy, Pregnancy, Bipolar, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a device that sends mild electrical signals to the brain and combines it with computer exercises. It aims to help people who have trouble controlling repetitive behaviors. The goal is to change brain activity and improve control over these behaviors.

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 data supports the effectiveness of the treatment Habit Override Practice, Habit Override Training, Transcranial Magnetic Stimulation, and Repetitive Transcranial Magnetic Stimulation for compulsive behavior?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can help reduce symptoms in people with obsessive-compulsive disorder (OCD) and other compulsive behaviors by improving brain function and reducing cravings. Studies have found that rTMS can lead to significant improvements in symptoms and decision-making, suggesting it may help people gain better control over compulsive behaviors. ^{1 2 3 4 5}

Is transcranial magnetic stimulation (TMS) safe for treating compulsive behaviors?

Research on repetitive transcranial magnetic stimulation (rTMS) shows it is generally safe for humans, with studies indicating it can improve symptoms in conditions like obsessive-compulsive disorder and addiction without significant safety concerns. ^{1 2 4 5 6}

How is the treatment of Transcranial Magnetic Stimulation + Habit Training for Compulsive Behavior different from other treatments?

This treatment is unique because it combines repetitive transcranial magnetic stimulation (rTMS), which uses magnetic fields to stimulate specific brain areas, with habit training to help control compulsive behaviors. Unlike traditional treatments that may rely on medication, this approach targets the brain's pathways directly to improve inhibitory control and reduce cravings. ^{2 4 5 7 8}

Research Team

Rebecca B Price, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

I am between 18 and 60 years old.

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.

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)

Trial Timeline

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

Treatment Details

Interventions

• Habit Override Practice (Behavioral Intervention)
• Transcranial Magnetic Stimulation (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.

Participant Groups

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+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation (rTMS) in the treatment of obsessive-compulsive disorder (OCD) and Tourette's syndrome (TS). [2016]

2. England pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation for the treatment of obsessive compulsive disorder: a double-blind controlled investigation. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Resting-State Functional Connectivity Differences Following Experimental Manipulation of the Orbitofrontal Cortex in Two Directions via Theta-Burst Stimulation. [2023]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation to treat substance use disorders and compulsive behavior. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Randomized sham-controlled trial of repetitive transcranial magnetic stimulation in treatment-resistant obsessive-compulsive disorder. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A Light in the Darkness: Repetitive Transcranial Magnetic Stimulation (rTMS) to Treat the Hedonic Dysregulation of Addiction. [2021]

7. Netherlands 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Pre-supplementary motor network connectivity and clinical outcome of magnetic stimulation in obsessive-compulsive disorder. [2022]