Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness

Schizophrenia Clinical Trial

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Official title:

Transdiagnostic Circuit Mapping of Prefrontal Targets in Accelerated Transcranial Magnetic Stimulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376734
• Other study ID #: 2024p000528
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: June 1, 2030

Study information

• Verified date: April 2024
• Source: Brigham and Women's Hospital
• Contact: Jessica Leach
• Phone: 617-525-3536
• Email: bwhtmstrials[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Participants will receive Transcranial Magnetic Stimulation (TMS) at a random location in the left prefrontal cortex, excluding sites that are potentially unsafe. Extensive behavioral testing will be conducted to determine which behaviors are modulated by stimulating which circuits.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: June 1, 2030
• Est. primary completion date: June 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65

• English proficiency sufficient for informed consent, questionnaires/tasks, and treatment

• Primary diagnosis of one of the following: major depressive disorder (MDD), obsessive-compulsive disorder (OCD), generalized anxiety disorder (GAD), or schizophrenia (determined by focal assessment using the Structured Clinical Interview for DSM-5)

• =20 on the Beck Depression Inventory for patients with MDD

• =16 on the Beck Anxiety Inventory for patients with GAD

• =16 on the Yale-Brown Obsessive-Compulsive Scale for patients with OCD

• =58 on the Positive and Negative Symptom Scale for patients with schizophrenia

• Stable psychotropic medication regimen, or remain medication free, for 4 weeks prior to treatment

• Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial

Exclusion Criteria:

• Active pregnancy as determined by a urine pregnancy test

• Cluster B personality disorders (antisocial personality disorder, borderline personality disorder, histrionic personality disorder, narcissistic personality disorder)

• Recent (within 4 weeks) or concurrent use of rapid acting antidepressant agent (ketamine/esketamine/ECT)

• Receiving or planning to receive other TMS treatments during course of participation

• History of:

• Neurosurgical intervention for mental illness

• Moderate to severe autism spectrum disorder

• Intellectual disability

• Severe cognitive impairment

• Significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis)

• Untreated or insufficiently treated endocrine disorder

• Eating disorders

• Treatment with investigational drug or intervention during the study period

• Current evidence of:

• Mania or hypomania

• Active suicidal ideation or a suicide attempt within the past year

• Contraindications to either TMS or MRI (e.g., metallic implants, etc.).

• Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal

• Elevated seizure risk

• For participants with schizophrenia:

• Evidence of impaired capacity to consent, e.g. impaired insight into illness, as deemed by a licensed psychiatrist or psychologist on the study team

• Hospitalization with psychosis in the past 6 months

• Positive urine drug screen for illicit substances

• Existing tinnitus (ringing in the ears)

• Any other condition deemed by the PI to interfere with the study or increase risk to the participant

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression, Anxiety
• Depressive Disorder
• Depressive Disorder, Major
• Generalized Anxiety Disorder
• Major Depressive Disorder
• Mental Disorder
• Mental Disorders
• Mood Disorders
• Obsessive-Compulsive Disorder
• Problem Behavior
• Psychiatric Disorder
• Schizophrenia

Intervention

Device:
• TMS
Accelerated TMS will be provided for 2 days using the same dosing regimen as the FDA-cleared SAINT protocol, ten 9-minute treatments per day.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clustering of multiple behavioral measures	Over 100 different behavioral outcomes will be tested, and the primary outcome is that stimulation of different circuits will selectively modify different behavioral clusters.; Changes in circuitry of behavioral traits measured by the phenotyping battery: Adult Temperament Questionnaire (ATQ); Anxiety Sensitivity Inventory (ASI); Beck Depression Inventory (BDI); Emotion Reactivity Scale (ERS); Beck Anxiety Inventory (BAI); Mini International Neuropsychiatric Interview (MINI)/ Structured Clinical Interview DSM-5 (SCID); NIH toolbox Emotion Battery (NIHTB); Neuro-QoL Scale (NQoL); Positive and Negative Affect Scale (PANAS); Positive and Negative Symptom Scale (PANSS); Ruminative Response Scale (RRS); Temporal Experience of Pleasure Scale (TEP); Testmybrain (TMB) Toolbox; Yale-Brown Obsessive-compulsive Scale (YBOCS)	through study completion, average of 3 months