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Trial record 3 of 37 for:    tms smoking

Circuitry-Guided Smoking Cessation in Schizophrenia

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ClinicalTrials.gov Identifier: NCT03281629
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaoming Du, University of Maryland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Nicotine Addiction Schizophrenia Device: Active TMS stimulation Device: Sham TMS stimulation Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Circuitry-Guided Smoking Cessation in Schizophrenia
Actual Study Start Date : May 18, 2018
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active TMS stimulation
Real active rTMS stimulation.
Device: Active TMS stimulation
Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.

Sham Comparator: Sham TMS stimulation
Sham repetitive TMS stimulation.
Device: Sham TMS stimulation
Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.




Primary Outcome Measures :
  1. Cigarette per day [ Time Frame: 7 months ]
    Cigarette per day (CPD) is measured to index smoking reduction and cessation.


Secondary Outcome Measures :
  1. Functional magnetic resonance imaging (fMRI) [ Time Frame: 7 months ]
    fMRI is used to evaluate the brain activities that are corresponding to the TMS effect on smoking reduction/cessation.

  2. Cotinine [ Time Frame: 7 months ]
    Cotinine level is an objective index of smoking status.

  3. End-expired carbon monoxide (CO) [ Time Frame: 7 months ]
    End-expired CO measure is an instant measure of smoking status.

  4. Electroencephalography (EEG) [ Time Frame: 7 months ]
    EEG is used to evaluate the brain activities that are corresponding to the TMS



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female between ages 18-60
  • Ability to give written informed consent (age 18 or above)
  • Smoking in the last one year or more and average cigarette per day ≥ 5 in the past 4 weeks.
  • For patient participants, Evaluation to Sign Consent (ESC) above10.

Exclusion Criteria:

  • Any history of seizures
  • Had smoking cessation treatment, clinical trial, or nicotine replacements within the past four weeks.
  • Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
  • Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, CNS infection or tumor, other significant brain neurological conditions.
  • Taking > 400 mg clozapine/day
  • Failed TMS screening questionnaire
  • Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
  • History of head injury with loss of consciousness over 10 minutes; history of brain surgery
  • Can not refrain from using alcohol and/or marijuana 24 hours or more & cigarette smoking one hour or more prior to experiments.
  • Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self report; or by positive pregnancy test).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281629


Contacts
Contact: Xiaoming Du, PhD 410-402-6036 xdu@mprc.umaryland.edu
Contact: Dawn Detamore 410-402-6820 ddetamor@mprc.umaryland.edu

Locations
United States, Maryland
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21228
Contact: Xiaoming Du, PhD    410-402-6036    xdu@mprc.umaryland.edu   
Contact: Dawn Detamore    410-402-6820    ddetamor@mprc.umaryland.edu   
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Xiaoming Du, MD University of Maryland

Responsible Party: Xiaoming Du, Assistant Professsor, University of Maryland
ClinicalTrials.gov Identifier: NCT03281629     History of Changes
Other Study ID Numbers: HP-00077085
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Xiaoming Du, University of Maryland:
Transcranial magnetic stimulation
schizophrenia
MRI
smoking

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders