Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia

Last updated: April 23, 2024
Sponsor: Stony Brook University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Smoking Cessation

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Treatment

Sham dTMS

Active deep transcranial magnetic stimulation (dTMS)

Clinical Study ID

NCT05724810
1R61DA056423
  • Ages 18-60
  • All Genders

Study Summary

Purpose of the study: Evaluate the effect of deep repetitive transcranial magnetic stimulation (deep rTMS; hereafter abbreviated as "dTMS") on synaptic density measured with positron emission tomography (PET) and the radiotracer [11C]UCB-J. The investigators also seek to link plasticity changes in the regions targeted by the electric field (especially, the insula) to changes in the functioning of insula circuits and behavioral cigarette usage in patients with schizophrenia (SCZ).

Importance of the study: This is the first study designed to directly evaluate the mechanism of action (MOA) of dTMS for smoking disruption in patients with SCZ. Patients with SCZ are a vulnerable population in high, immediate need of new smoking therapeutics for reducing premature morbidity and mortality.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ages 18-60
  2. DSM-5 criteria for schizophreniform, schizophrenia, schizoaffective disorder, orpsychotic disorder not otherwise specified (NOS).
  3. DSM-5 diagnosis of nicotine use disorder with current daily smoking, and a desire tocut down or quit.
  4. Negative urine toxicology (other than cannabis) maintained throughout studyparticipation
  5. Fluent English Speaker
  6. Capacity for informed consent

Exclusion

Exclusion Criteria:

  1. Clinically significant psychopathology other than schizophrenia, schizophreniform,schizoaffective disorder, or psychotic disorder NOS
  2. Current or past substance use disorder, except TUD
  3. Current use of smoking cessation medications/products
  4. Change in schizophrenia medication within 4 weeks
  5. Hospitalization in the last 3 months
  6. History of suicidal or homicidal tendencies
  7. History of epilepsy, stroke, cerebral aneurysm, significant head injury resulting in >10 min loss of consciousness, movement disorder, clinically significant electrolyteabnormalities, or use of clozapine (seizure risks)
  8. Pregnancy or lactation (females)
  9. Lack of effective birth control (females)
  10. Contraindications to MRI or PET
  11. Clinical Global Impressions (CGI) rating of 6 (severely ill) or 7 (extremely ill)
  12. Prisoners
  13. Contraindications to dTMS*
  • The FDA website currently states that the Brainsway device used in this study iscontraindicated for patients who have "metallic objects or implanted stimulatordevices in or near the head, including cochlear implants, deep brain stimulators,vagus nerve stimulators, other implanted electrodes or stimulators, aneurysmclips or coils, stents, bullet fragments, jewelry and hair barrettes." Theinvestigators will monitor the FDA guidelines and implement any changes to theinclusion/exclusion criteria based on their most updated recommendations.

Study Design

Total Participants: 38
Treatment Group(s): 2
Primary Treatment: Sham dTMS
Phase:
Study Start date:
April 04, 2023
Estimated Completion Date:
August 31, 2028

Connect with a study center

  • Stony Brook University

    Stony Brook, New York 11794
    United States

    Active - Recruiting

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