Trial Outcomes & Findings for Behavioral Impact and Neural Correlates of Network-based Brain Stimulation in Schizophrenia (NCT NCT07190352)
NCT ID: NCT07190352
Last Updated: 2026-07-30
Results Overview
Nicotine craving is assessed using 0-10 Visual Analog Scale (VAS) immediately before and after rTMS application. The VAS ranges from 0 to 10, where 0 indicates "no craving," and higher numbers indicate more craving.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Immediately prior to and following rTMS.
Results posted on
2026-07-30
Participant Flow
Participant milestones
| Measure |
iTBS, Sham, cTBS
In this randomized, sham-controlled crossover study, all participants (individuals with schizophrenia who use nicotine) receive 3 separate rTMS interventions, the order of which is randomized. This is the arm that received interventions in the following order: iTBS, sham, cTBS
|
iTBS, cTBS, Sham
In this randomized, sham-controlled crossover study, all participants (individuals with schizophrenia who use nicotine) receive 3 separate rTMS interventions, the order of which is randomized. This is the arm that received interventions in the following order: iTBS, cTBS, sham
|
Sham, iTBS, cTBS
In this randomized, sham-controlled crossover study, all participants (individuals with schizophrenia who use nicotine) receive 3 separate rTMS interventions, the order of which is randomized. This is the arm that received interventions in the following order: sham, iTBS, cTBS
|
Sham, cTBS, iTBS
In this randomized, sham-controlled crossover study, all participants (individuals with schizophrenia who use nicotine) receive 3 separate rTMS interventions, the order of which is randomized. This is the arm that received interventions in the following order: sham, cTBS, iTBS
|
cTBS, iTBS, Sham
In this randomized, sham-controlled crossover study, all participants (individuals with schizophrenia who use nicotine) receive 3 separate rTMS interventions, the order of which is randomized. This is the arm that received interventions in the following order: cTBS, iTBS, sham
|
|---|---|---|---|---|---|
|
Baseline (2 Days)
STARTED
|
4
|
1
|
1
|
4
|
1
|
|
Baseline (2 Days)
COMPLETED
|
3
|
1
|
1
|
4
|
1
|
|
Baseline (2 Days)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
|
First Intervention (2 Days)
STARTED
|
3
|
1
|
1
|
4
|
1
|
|
First Intervention (2 Days)
COMPLETED
|
3
|
1
|
1
|
4
|
1
|
|
First Intervention (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (2 Days)
STARTED
|
3
|
1
|
1
|
4
|
1
|
|
Second Intervention (2 Days)
COMPLETED
|
3
|
1
|
1
|
4
|
1
|
|
Second Intervention (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (2 Days)
STARTED
|
3
|
1
|
1
|
4
|
1
|
|
Third Intervention (2 Days)
COMPLETED
|
3
|
1
|
1
|
4
|
1
|
|
Third Intervention (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
iTBS, Sham, cTBS
In this randomized, sham-controlled crossover study, all participants (individuals with schizophrenia who use nicotine) receive 3 separate rTMS interventions, the order of which is randomized. This is the arm that received interventions in the following order: iTBS, sham, cTBS
|
iTBS, cTBS, Sham
In this randomized, sham-controlled crossover study, all participants (individuals with schizophrenia who use nicotine) receive 3 separate rTMS interventions, the order of which is randomized. This is the arm that received interventions in the following order: iTBS, cTBS, sham
|
Sham, iTBS, cTBS
In this randomized, sham-controlled crossover study, all participants (individuals with schizophrenia who use nicotine) receive 3 separate rTMS interventions, the order of which is randomized. This is the arm that received interventions in the following order: sham, iTBS, cTBS
|
Sham, cTBS, iTBS
In this randomized, sham-controlled crossover study, all participants (individuals with schizophrenia who use nicotine) receive 3 separate rTMS interventions, the order of which is randomized. This is the arm that received interventions in the following order: sham, cTBS, iTBS
|
cTBS, iTBS, Sham
In this randomized, sham-controlled crossover study, all participants (individuals with schizophrenia who use nicotine) receive 3 separate rTMS interventions, the order of which is randomized. This is the arm that received interventions in the following order: cTBS, iTBS, sham
|
|---|---|---|---|---|---|
|
Baseline (2 Days)
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Behavioral Impact and Neural Correlates of Network-based Brain Stimulation in Schizophrenia
Baseline characteristics by cohort
| Measure |
All Study Participants
n=11 Participants
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.
iTBS to the DMN: Intermittent theta-burst frequency rTMS (iTBS) targeted to the parietal node of the default mode network.
cTBS to the DMN: Continuous theta-burst frequency rTMS (cTBS) targeted to the parietal node of the default mode network
Sham rTMS: 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.
|
|---|---|
|
Age, Continuous
|
38.73 years
STANDARD_DEVIATION 13.70 • n=20 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
PANSS (Positive and Negative Syndrome Scale) Total
|
55.27 units on a scale.
STANDARD_DEVIATION 11.84 • n=20 Participants
|
PRIMARY outcome
Timeframe: Immediately prior to and following rTMS.Nicotine craving is assessed using 0-10 Visual Analog Scale (VAS) immediately before and after rTMS application. The VAS ranges from 0 to 10, where 0 indicates "no craving," and higher numbers indicate more craving.
Outcome measures
| Measure |
Nicotine Users With Schizophrenia
n=10 Participants
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.
iTBS to the DMN: Intermittent theta-burst frequency rTMS (iTBS) targeted to the parietal node of the default mode network.
cTBS to the DMN: Continuous theta-burst frequency rTMS (cTBS) targeted to the parietal node of the default mode network
Sham rTMS: 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.
|
cTBS
cTBS to the DMN: Continuous theta-burst frequency rTMS (cTBS) targeted to the parietal node of the default mode network
|
Sham
Sham rTMS: 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 Craving
iTBS Change in Craving
|
2.5 score on a scale
Standard Error .95
|
—
|
—
|
|
Nicotine Craving
cTBS Change in Craving
|
-0.1 score on a scale
Standard Error .95
|
—
|
—
|
|
Nicotine Craving
Sham Change in Craving
|
-0.4 score on a scale
Standard Error .95
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately prior to and following rTMS.Functional connectivity of the entire default mode network (DMN) will be measured via resting-state fMRI collected immediately before and after rTMS. Whole network connectivity will be calculated by extracting the BOLD signal from from 7 standard nodes of the DMN (Raichle 2011), placing 6mm spheres at these coordinates, and calculating the average resting-state functional connectivity between all nodes. Higher values indicate smore strongly correlated BOLD signals in the nodes of the DMN.
Outcome measures
| Measure |
Nicotine Users With Schizophrenia
n=10 Participants
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.
iTBS to the DMN: Intermittent theta-burst frequency rTMS (iTBS) targeted to the parietal node of the default mode network.
cTBS to the DMN: Continuous theta-burst frequency rTMS (cTBS) targeted to the parietal node of the default mode network
Sham rTMS: 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.
|
cTBS
n=10 Participants
cTBS to the DMN: Continuous theta-burst frequency rTMS (cTBS) targeted to the parietal node of the default mode network
|
Sham
n=10 Participants
Sham rTMS: 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.
|
|---|---|---|---|
|
Resting State Functional Connectivity
immediately prior to TMS
|
8.64 z-transformed pearson's R
Standard Error 2.12
|
9.03 z-transformed pearson's R
Standard Error 3.07
|
8.38 z-transformed pearson's R
Standard Error 1.68
|
|
Resting State Functional Connectivity
immediately following TMS
|
8.50 z-transformed pearson's R
Standard Error 3.559
|
8.74 z-transformed pearson's R
Standard Error 2.46
|
8.41 z-transformed pearson's R
Standard Error 3.40
|
Adverse Events
iTBS
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
cTBS
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
iTBS
n=10 participants at risk
iTBS to the DMN: Intermittent theta-burst frequency rTMS (iTBS) targeted to the parietal node of the default mode network.
|
cTBS
n=10 participants at risk
cTBS to the DMN: Continuous theta-burst frequency rTMS (cTBS) targeted to the parietal node of the default mode network
|
Sham
n=10 participants at risk
Sham rTMS: 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.
|
|---|---|---|---|
|
Nervous system disorders
Headache or neck pain
|
20.0%
2/10 • Number of events 2 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Nervous system disorders
Trouble Concentrating
|
10.0%
1/10 • Number of events 1 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Nervous system disorders
Hypomania
|
10.0%
1/10 • Number of events 1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place