Behavioral Impact and Neural Correlates of Network-based Brain Stimulation in Schizophrenia

NCT07190352 | Completed FDA Device

• 1 other identifier: 2021P000749
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aims of this study are to investigate the behavioral effects of applying targeted transcranial magnetic stimulation (TMS) to a node of the brain network subserving attention in schizophrenia and schizoaffective disorder and to correlate these effects to changes in brain network connectivity. Assumptions: -Cerebral activity can be investigated through the correlated activity of cortical nodes that constitute functional brain networks -Behavior can be correlated to the strength of correlated activity between and within nodes of these cortical networks -TMS to targeted nodes leads to changes in patterns of activity in these cortical networks Hypothesis: TMS to a node of the attention network in schizophrenia or schizoaffective disorder will influence network connectivity leading to measurable and predictable effects on attention.

Conditions

SCHIZOPHRENIA 1 (Disorder); Nicotine Use

Keywords

iTBS; cTBS; Schizophrenia; nicotine; sham; TMS

Outcome Measures

Primary Outcomes (1)

• Nicotine Craving

  Nicotine craving is assessed using 0-10 Visual Analog Scale (VAS) immediately before and after rTMS application.

  Immediately prior to and following rTMS.

Secondary Outcomes (1)

• DMN Connectivity

  Immediately prior to and following rTMS.

Study Arms (1)

Nicotine Users with Schizophrenia

EXPERIMENTAL

Subjects must report that they have been given a diagnosis of schizophrenia or schizoaffective disorder by a mental health professional and be a current nicotine user.

Device: iTBS to the DMN; Device: cTBS to the DMN; Device: Sham rTMS

Interventions

iTBS to the DMN DEVICE

Intermittent theta-burst frequency rTMS (iTBS) targeted to the parietal node of the default mode network.

Nicotine Users with Schizophrenia

cTBS to the DMN DEVICE

Continuous theta-burst frequency rTMS (cTBS) targeted to the parietal node of the default mode network

Nicotine Users with Schizophrenia

Sham rTMS DEVICE

Sham rTMS: coil flipped 180 degrees and applied to the parietal node of the DMN using an iTBS sequence. For this sham condition, rTMS felt and sounded like active stimulation, but no actual stimulation was delivered.

Nicotine Users with Schizophrenia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-65 years
• At pre-visit screening (see attached phone screening questionnaire): Subjects must report that they have been given a diagnosis of schizophrenia or schizoaffective disorder by a mental health professional
• Current smoker (expired air CO of 5ppm or higher)
• Must be able to read, speak and understand English
• Must be judged by study staff to be capable of completing the study procedures
• Diagnosis of either schizophrenia or schizoaffective disorder according to DSM-V criteria and confirmed by SCID\[26\]
• Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens.

You may not qualify if:

• DSM-V intellectual disability
• Substance use disorder within the past three months
• Any history of a progressive or genetic neurologic disorder (e.g. Parkinson's disease, multiple sclerosis, tuberous sclerosis, Alzheimer's Disease) or acquired neurological disease (e.g. stroke, traumatic brain injury, tumor), including intracranial lesions
• History of head trauma resulting in any loss of consciousness (\>15 minutes) or neurological sequelae
• Current history of poorly controlled headaches including chronic medication for migraine prevention
• History of fainting spells of unknown or undetermined etiology that might constitute seizures
• History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
• Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
• Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement)
• Any devices such as pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD
• All female participants of child-bearing age will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study
• Any changes in medications or hospitalizations within the past 30 days.
• Subjects who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Randomized, crossover study comparing a single session of iTBS, cTBS, and sham all targeted to the DMN in people with schizophrenia who use nicotine.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 24, 2025
• Study Start: October 4, 2021
• Primary Completion: October 3, 2022
• Study Completion: October 3, 2022
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)