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出境医 / 临床实验 / Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking
Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking
Study Description
Brief Summary:
The purpose of this research study is to examine the effects of theta-burst Transcranial Magnetic Stimulation on inhibitory control and smoking among adult cigarette smokers.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tobacco Use Disorder | Device: Intermittent Theta-burst stimulation (iTBS) Device: Continuous Theta-burst stimulation (cTBS) | Phase 2 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Basic Science |
| Official Title: | Examining the Effects of Theta Burst Stimulation on Corticothalamic Mediated Inhibitory Control and Smoking Relapse Vulnerability |
| Actual Study Start Date : | September 26, 2019 |
| Estimated Primary Completion Date : | April 30, 2021 |
| Estimated Study Completion Date : | April 30, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Intermittent Theta-burst stimulation (iTBS)
Cross-over design - participants will receive both experimental treatments.
|
Device: Intermittent Theta-burst stimulation (iTBS)
Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected.
Device: Continuous Theta-burst stimulation (cTBS) Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Continuous TBS (cTBS) which is thought to temporarily dampen brain activity in that specific area.
|
|
Experimental: Continuous Theta-burst stimulation (cTBS)
Cross-over design - participants will receive both experimental treatments.
|
Device: Intermittent Theta-burst stimulation (iTBS)
Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected.
Device: Continuous Theta-burst stimulation (cTBS) Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Continuous TBS (cTBS) which is thought to temporarily dampen brain activity in that specific area.
|
Outcome Measures
Primary Outcome Measures :
- Cigarette Smoking Abstinence [ Time Frame: 3 weeks ]Measure the time to first cigarette within a 2 hour period after TMS.
- Magnitude of change in fMRI brain response to images [ Time Frame: 3 weeks ]Measure the effects of TMS on fMRI BOLD response during an inhibitory control task.
- Magnitude of change in fMRI brain connectivity [ Time Frame: 3 weeks ]Measure the effects of TMS on inhibitory control task performance
- Cigarette Smoking Puffs [ Time Frame: 3 weeks ]Number of puffs are measured of first cigarette smoked after TMS
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Be between the ages of 18 and 65.
- Be in stable mental and physical health.
- Be willing to provide informed consent.
- Be able to comply with protocol requirements and likely to complete all study procedures.
- Be a current nicotine dependent cigarette smoker (smoke ≥10 cigs/day) with a minimum smoking history of smoking an average of ≥ 10 cigs/day over the past two years.
Exclusion Criteria:
-
1. Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).
2. Contraindication to TMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for > 15 minutes, implanted electronic device, metal in the head, or pregnancy, as indicated by a positive urine pregnancy test at screening).
3. Any use of substances that lower seizure threshold (such as thyroid medications or cocaine).
4. History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.
5. History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.
6. Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea.
7. BAC greater than 0.0. 8. Any other condition or concern that in the Investigator's opinion would impact participant safety, compliance with study instructions, or potentially confound the interpretation of the study results.
Contacts and Locations
Contacts
| Contact: Madhura Athreya, MS | 5738822977 | athreyam@health.missouri.edu | |
| Contact: Brett Froeliger, PhD | 5738824785 | froeligerb@health.missouri.edu |
Locations
| United States, Missouri | |
| University of Missouri - Columbia | Recruiting |
| Columbia, Missouri, United States, 65211 | |
| Contact: Brett Froeliger, PhD 573-882-4785 froeligerb@health.missouri.edu | |
| Contact: Madhura Athreya, MS 5738822977 athreyam@health.missouri.musc.edu | |
Sponsors and Collaborators
University of Missouri-Columbia
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 10, 2019 | ||||||||
| First Posted Date ICMJE | May 22, 2019 | ||||||||
| Last Update Posted Date | November 19, 2020 | ||||||||
| Actual Study Start Date ICMJE | September 26, 2019 | ||||||||
| Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking | ||||||||
| Official Title ICMJE | Examining the Effects of Theta Burst Stimulation on Corticothalamic Mediated Inhibitory Control and Smoking Relapse Vulnerability | ||||||||
| Brief Summary | The purpose of this research study is to examine the effects of theta-burst Transcranial Magnetic Stimulation on inhibitory control and smoking among adult cigarette smokers. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE | Tobacco Use Disorder | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Froeliger B, McConnell PA, Bell S, Sweitzer M, Kozink RV, Eichberg C, Hallyburton M, Kaiser N, Gray KM, McClernon FJ. Association Between Baseline Corticothalamic-Mediated Inhibitory Control and Smoking Relapse Vulnerability. JAMA Psychiatry. 2017 Apr 1;74(4):379-386. doi: 10.1001/jamapsychiatry.2017.0017. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
40 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | April 30, 2021 | ||||||||
| Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03960138 | ||||||||
| Other Study ID Numbers ICMJE | 00074836 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Brett Froeliger, University of Missouri-Columbia | ||||||||
| Study Sponsor ICMJE | University of Missouri-Columbia | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | University of Missouri-Columbia | ||||||||
| Verification Date | November 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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