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Investigator completing residency program and leaving for a new job
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The purpose if this study is to determine if five treatments of repetitive transcranial magnetic stimulation (rTMS) can reduce craving for cigarettes in smokers. rTMS uses magnetic pulses to stimulate the brain and is currently approved for the treatment of major depressive disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Experimental | 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session. |
|
| Sham | Sham Comparator | 5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active rTMS with MagVenture MagPro double blind rTMS system | Device | 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability Measured by Percent of Participants Completing the rTMS Course | Percent of participants completing the 5 session rTMS course. Hypothesize >75% of participants will complete the 5 treatments. | 1 day (single visit) |
| Decrease in Cue Induced Nicotine Craving | Nicotine craving evaluated using Questionnaire on Smoking Urges- Brief (QSU-B) questions modified to a 0-100 analog rating. Higher scores meaning a higher level of craving. | During the one day visit |
| Measure | Description | Time Frame |
|---|---|---|
| Reduce in Self Reported Smoking | An exploratory outcome will be the determination if participants receiving active rTMS report decreased levels of smoking 1 week and 2 weeks after rTMS course. | 1 week and 2 weeks after rTMS |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| David Friedrich, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUSC Institute of Psychiatry | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active rTMS | 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session. Active rTMS with MagVenture MagPro double blind rTMS system: 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session. |
| FG001 | Sham | 5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention. Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active rTMS | 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session. Active rTMS with MagVenture MagPro double blind rTMS system: 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Tolerability Measured by Percent of Participants Completing the rTMS Course | Percent of participants completing the 5 session rTMS course. Hypothesize >75% of participants will complete the 5 treatments. | Posted | Count of Participants | Participants | 1 day (single visit) |
|
Single visit of approximately 6 hours
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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 rTMS | 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session. Active rTMS with MagVenture MagPro double blind rTMS system: 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Slight scalp discomfort | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Immediately resolved |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Friedrich | MUSC | 843-792-9888 | friedric@musc.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 | Jan 30, 2018 | Sep 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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Randomized, double blind, control
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Randomized double blind control using a sham rTMS system
| Sham rTMS | Device | Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads |
|
| BG001 | Sham | 5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention. Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention. Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads |
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|
| Primary | Decrease in Cue Induced Nicotine Craving | Nicotine craving evaluated using Questionnaire on Smoking Urges- Brief (QSU-B) questions modified to a 0-100 analog rating. Higher scores meaning a higher level of craving. | Posted | Mean | Full Range | Percent change on craving scale | During the one day visit |
|
|
|
| Secondary | Reduce in Self Reported Smoking | An exploratory outcome will be the determination if participants receiving active rTMS report decreased levels of smoking 1 week and 2 weeks after rTMS course. | Participants did not return follow up phone call | Posted | 1 week and 2 weeks after rTMS |
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|
| 0 |
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | Sham | 5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention. Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads | 0 | 3 | 0 | 3 | 1 | 3 |
|
| Mild Nausea | General disorders | Non-systematic Assessment | transient, self resolved |
|
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