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In this pilot study, the feasibility of using tDCS (a non-invasive brain stimulation technique) while performing a task requiring cognitive flexibility will be examined in smokers and initial data will be collected regarding the effect of tDCS on smoking cessation behaviors. Smokers will be randomized to receive either active or sham tDCS daily for 5 days after which they will attempt to quit smoking. Smoking behavior after the attempted quit date will be assessed at four weekly visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tDCS | Experimental | Participants receive active tDCS for five consecutive days before attempting to quit smoking |
|
| sham tDCS | Sham Comparator | Participants receive sham tDCS for five consecutive days before attempting to quit smoking |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active tDCS | Device | two 13 minute tDCS sessions separated by 20 minutes in between |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Willing to Complete 5 Days of tDCS or Sham | As a feasibility study, the primary endpoint will be to determine if smokers are willing to enroll into and complete a study evaluating tDCS. Number of smokers enrolled and number who complete the 5 day tDCS procedures will be assessed. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Cigarettes Smoked Per Day | Change in number of cigarettes smoked per day from the 1 week training period to the 4 week post quit period. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical and Translational Sciences Institute | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | Participants receive active tDCS for five consecutive days before attempting to quit smoking active tDCS: two 13 minute tDCS sessions separated by 20 minutes in between |
| FG001 | Sham tDCS | Participants receive sham tDCS for five consecutive days before attempting to quit smoking sham tDCS: sham tDCS session given for same length of time as active |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Number randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | Participants receive active tDCS for five consecutive days before attempting to quit smoking active tDCS: two 13 minute tDCS sessions separated by 20 minutes in between |
| BG001 | Sham tDCS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Willing to Complete 5 Days of tDCS or Sham | As a feasibility study, the primary endpoint will be to determine if smokers are willing to enroll into and complete a study evaluating tDCS. Number of smokers enrolled and number who complete the 5 day tDCS procedures will be assessed. | Number randomized | Posted | Count of Participants | Participants | 5 days |
|
5 days (time period during which participants received either active or sham tDCS)
Before and after each laboratory session, participants were asked about the presence and severity of 11 specific potential adverse events: 1) Headache; 2) Neck Pain; 3) Scalp Pain; 4) Tingling; 5) Itching; 6) Burning Sensation; 7) Skin Redness; 8) Sleepiness / Fatigue; 9) Poor Concentration; 10) Acute Mood Change; 11) Nausea; 12) An open ended option labeled Other
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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 tDCS | Participants receive active tDCS for five consecutive days before attempting to quit smoking active tDCS: two 13 minute tDCS sessions separated by 20 minutes in between |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Kotlyar | University of Minnesota | 612-625-1160 | kotly001@umn.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 | May 16, 2018 | Nov 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| sham tDCS |
| Device |
sham tDCS session given for same length of time as active |
|
Participants receive sham tDCS for five consecutive days before attempting to quit smoking
sham tDCS: sham tDCS session given for same length of time as active
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Number of Cigarettes Smoked Per Day | Change in number of cigarettes smoked per day from the 1 week training period to the 4 week post quit period. | Posted | Mean | Standard Error | cigarettes per day | 4 weeks |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 6 |
| 8 |
| EG001 | Sham tDCS | Participants receive sham tDCS for five consecutive days before attempting to quit smoking sham tDCS: sham tDCS session given for same length of time as active | 0 | 8 | 0 | 8 | 4 | 8 |
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tingling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Burning sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sleepiness | General disorders | Systematic Assessment |
|
| Poor Concentration | Nervous system disorders | Systematic Assessment |
|
| Mood Change | Psychiatric disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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