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| ID | Type | Description | Link |
|---|---|---|---|
| UG3DA047685 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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In a double-blinded, randomized, parallel controlled design, patients with schizophrenia spectrum disorder will be exposed to active or sham repetitive transcranial magentic stimulation (TMS) which was guided by functional magnetic resonance image (MRI). Smoking reduction/cessation and brain functional connectivity changes will be assessed at baseline, different stages of rTMS and/or follow-ups.
Neuroimaging studies suggest that high rate of smoking in patients with schizophrenia may be due to an overlap of nicotine addiction related circuitries and schizophrenia related circuitries, such that schizophrenia impact some of the same circuitries that increase risks for severe nicotine addiction in general. Those identified overlapping circuitries have been linked to several key features of nicotine addiction and can be represented by resting state functional connectivities. Transcranial magnetic stimulation (TMS) provides a non-invasive means for altering brain electrical neural activity. TMS has been approved by FDA for treatment of depression. Other applications have not been approved but it has been used in a wide range of clinical research especially in neurology and psychiatry. There are preliminarily significant improvements in treatments of smoking cessation in schizophrenia using TMS with small samples, but those treatments are not robust in larger samples. The high inter-subject variability limits the efficacy of TMS treatment in schizophrenia patients. We aim to develop a TMS method targeting special brain circuits that are both smoking cessation and schizophrenia related. If the corresponding brain circuits were successfully modulated, the treatment efficacy will be significantly improved and schizophrenia patients will benefit from the TMS treatment of smoking cessation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TMS stimulation | Active Comparator | Real active rTMS stimulation. |
|
| Sham TMS stimulation | Sham Comparator | Sham repetitive TMS stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active TMS stimulation | Device | Multiple trains of active transcranial magnetic stimulation in a day, for multiple days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cigarette Per Day | Cigarette per day (CPD) is measured to index smoking reduction and cessation. The change of CPD between baseline and end-of-treatment (1-month time point), 3-month follow up (4-month time point) and 6-month follow up (7-month time point) are reported. Negative values of the change of CPD indicate reductions in cigarette consumption. | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Magnetic Resonance Imaging (fMRI) | Resting-state functional connectivity (rsFC) obtained from fMRI is used to evaluate the TMS effect on smoking cessation. The strength of rsFC was first defined by correlation coefficient (r). Because the distribution of r values is highly skewed, z scores (normally distributed) were computed via fisher r-to-z transform. The z score central value (i.e., z score of 0) represents no relationship between the two brain regions. A positive (negative) z score indicates a positive (negative) association between the two brain regions. According to our pilot data determined from a separate study, stronger rsFC (i.e., larger positive z score) was related to less smoking severity. The changes of rsFC between baseline and end-of-treatment (1-month time point) and 3-month follow up (4-month time point) are reported. A positive (negative) value of rsFC change suggests the rsFC was enhanced (weakened) by the intervention. No fMRI data were collected at 6-month follow up (7-month time point). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoming Du, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore | Baltimore | Maryland | 21228 | United States |
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Fourteen enrolled participants were excluded from the study before assignment to groups. Six of them were excluded because they failed inclusion/exclusion criteria; six of them were excluded due to schedule conflict; one was excluded because the participant cannot fit into MRI scanner; one was excluded because the participant changed mind and decided to quit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active TMS Stimulation | Real active rTMS stimulation. Active TMS stimulation: Multiple trains of active transcranial magnetic stimulation in a day, for multiple days. |
| FG001 | Sham TMS Stimulation | Sham repetitive TMS stimulation. Sham TMS stimulation: Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active TMS Stimulation | Real active rTMS stimulation. Active TMS stimulation: Multiple trains of active transcranial magnetic stimulation in a day, for multiple days. |
| BG001 | Sham TMS Stimulation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cigarette Per Day | Cigarette per day (CPD) is measured to index smoking reduction and cessation. The change of CPD between baseline and end-of-treatment (1-month time point), 3-month follow up (4-month time point) and 6-month follow up (7-month time point) are reported. Negative values of the change of CPD indicate reductions in cigarette consumption. | Posted | Mean | Standard Deviation | cigarettes per day | 7 months |
|
From baseline to the time when the participant completes or quits the study (up to 7 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active TMS Stimulation | Real active rTMS stimulation. Active TMS stimulation: Multiple trains of active transcranial magnetic stimulation in a day, for multiple days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial muscle twitching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Xiaoming Du | Maryland Psychiatric Research Center, University of Maryland School of Medicine | 410 402 6036 | xdu@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2022 | Oct 24, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 7, 2022 | Oct 19, 2022 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| D012559 | Schizophrenia |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| Sham TMS stimulation | Device | Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days. |
|
| 4 months |
| Cotinine | Cotinine level is an objective index of smoking status. Higher level of cotinine indicates more nicotine consumption. The change of cotinine level between baseline and end-of-treatment (1-month time point) is reported. Cotinine data were not collected at 3-month follow up (4-month time point) or 6-month follow up (7-month time point). | 1 month |
| End-expired Carbon Monoxide (CO) | End-expired CO measure is an instant measure of smoking status. Higher CO level indicates more nicotine consumption. The change of CO level between baseline and end-of-treatment (1-month time point) is reported. No CO data were collected at 3-month follow up (4-month time point) or 6-month follow up (7-month time point). | 1 month |
| Normalized Gamma Power of Auditory Static State Response (ASSR) From Electroencephalography (EEG) | EEG is used to evaluate the brain activities that are corresponding to the TMS. Auditory static state response (ASSR) at gamma frequency (i.e., 40 Hz) is obtained from the EEG recording. The gamma power of ASSR was normalized as the ratio between the power at 40 Hz (i.e., gamma power) and the power of its neighboring frequencies (i.e., 39 and 41 Hz). Increased normalized gamma ASSR is usually related to the improvement of psychosis symptoms. The change of ASSR between baseline and end-of-treatment (1-month time point) and 3-month follow up (4-month time point) are reported. No EEG data were collected at 6-month follow up (7-month time point). | 4 months |
| Participant's schedule change and cannot participate in the study |
|
Sham repetitive TMS stimulation.
Sham TMS stimulation: Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Functional Magnetic Resonance Imaging (fMRI) | Resting-state functional connectivity (rsFC) obtained from fMRI is used to evaluate the TMS effect on smoking cessation. The strength of rsFC was first defined by correlation coefficient (r). Because the distribution of r values is highly skewed, z scores (normally distributed) were computed via fisher r-to-z transform. The z score central value (i.e., z score of 0) represents no relationship between the two brain regions. A positive (negative) z score indicates a positive (negative) association between the two brain regions. According to our pilot data determined from a separate study, stronger rsFC (i.e., larger positive z score) was related to less smoking severity. The changes of rsFC between baseline and end-of-treatment (1-month time point) and 3-month follow up (4-month time point) are reported. A positive (negative) value of rsFC change suggests the rsFC was enhanced (weakened) by the intervention. No fMRI data were collected at 6-month follow up (7-month time point). | Posted | Mean | Standard Deviation | z score of functional connectivity | 4 months |
|
|
|
| Secondary | Cotinine | Cotinine level is an objective index of smoking status. Higher level of cotinine indicates more nicotine consumption. The change of cotinine level between baseline and end-of-treatment (1-month time point) is reported. Cotinine data were not collected at 3-month follow up (4-month time point) or 6-month follow up (7-month time point). | Posted | Mean | Standard Deviation | ng/ml | 1 month |
|
|
|
| Secondary | End-expired Carbon Monoxide (CO) | End-expired CO measure is an instant measure of smoking status. Higher CO level indicates more nicotine consumption. The change of CO level between baseline and end-of-treatment (1-month time point) is reported. No CO data were collected at 3-month follow up (4-month time point) or 6-month follow up (7-month time point). | Posted | Mean | Standard Deviation | ppm | 1 month |
|
|
|
| Secondary | Normalized Gamma Power of Auditory Static State Response (ASSR) From Electroencephalography (EEG) | EEG is used to evaluate the brain activities that are corresponding to the TMS. Auditory static state response (ASSR) at gamma frequency (i.e., 40 Hz) is obtained from the EEG recording. The gamma power of ASSR was normalized as the ratio between the power at 40 Hz (i.e., gamma power) and the power of its neighboring frequencies (i.e., 39 and 41 Hz). Increased normalized gamma ASSR is usually related to the improvement of psychosis symptoms. The change of ASSR between baseline and end-of-treatment (1-month time point) and 3-month follow up (4-month time point) are reported. No EEG data were collected at 6-month follow up (7-month time point). | Posted | Mean | Standard Deviation | ratio | 4 months |
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|
| 0 |
| 18 |
| 0 |
| 18 |
| 14 |
| 18 |
| EG001 | Sham TMS Stimulation | Sham repetitive TMS stimulation. Sham TMS stimulation: Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days. | 1 | 12 | 0 | 12 | 6 | 12 |
| Eye blinks | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| headache | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Uncomfortable click sounds | Ear and labyrinth disorders | Systematic Assessment |
|
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| D001523 |
| Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |