Effects of rTMS on Cigarette Smoking and Cognition in Schizophrenia
rTMSsmokelab
Effects of Repetitive Transcranial Magnetic Stimulation on Cigarette Smoking and Cognitive Function in Smokers With and Without Schizophrenia
1 other identifier
interventional
27
1 country
1
Brief Summary
Cigarette smoking rates are extremely high in persons with schizophrenia and this increases the risk of disease and death due to tobacco-related disorders. One of the features of schizophrenia is reduced cognitive abilities, such as poor attention and memory. It is thought that people with schizophrenia smoke cigarettes to reduce these cognitive problems, as nicotine can improve cognitive function in these people. When people with schizophrenia stop smoking it causes further cognitive difficulties, which makes quitting harder for them compared to people without schizophrenia. A method called repetitive transcranial magnetic stimulation (rTMS) allows clinicians to give repeated magnetic pulses through the scalp to cause changes in brain activity and behaviour. rTMS can improve cognitive function in people with schizophrenia. Studies have also shown that rTMS can reduce tobacco craving and consumption of cigarettes. Therefore, we believe that rTMS will improve the cognitive deficits observed during cigarette smoking abstinence and help reduce cravings for cigarettes. Ultimately, rTMS may help smokers with schizophrenia who can't quit smoking with available treatments. This study will examine the effect of rTMS on tobacco cravings and cognitive problems produced by overnight abstinence from cigarette smoking in persons with schizophrenia in comparison to people without mental illness who smoke. Important information about the potential of rTMS for the treatment of cognitive deficits and tobacco addiction in schizophrenia will be obtained. Providing more effective smoking cessation treatments in people with schizophrenia may lead to improved physical and mental health for these patients, who are extremely susceptible to tobacco addiction and tobacco-related illness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Apr 2012
Typical duration for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2012
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedSeptember 9, 2015
September 1, 2015
3.4 years
January 25, 2012
September 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cigarette craving as assessed by Tiffany Questionnaire for Smoking Urges (TQSU)
Craving will be assessed using the TQSU, a 32-item list of signs and symptoms of nicotine cravings and urges to smoke which subjects rate how strongly they agree or disagree with the statements on a scale of 1 (strongly disagree) to 7 (strongly agree).
Pre- and post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
Secondary Outcomes (10)
Cigarette withdrawal using the Minnesota Nicotine Withdrawal Scale (MNWS)
Pre- and post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
Expired breath carbon monoxide (CO) levels
Pre- and post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 1 and 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
Plasma nicotine/cotinine levels
Pre- and post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
Continuous Performance Test-X (CPT-X)
Post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
N-back
Post rTMS/sham treatment week 1 and 2: at baseline smoking as usual (day 2), following over-night smoking abstinence (day 3am) and smoking reinstatement (day 3pm)
- +5 more secondary outcomes
Study Arms (2)
Repetitive Transcranial Magnetic Stimulation (rTMS)
ACTIVE COMPARATORSham rTMS
PLACEBO COMPARATORInterventions
Subjects will undergo two testing weeks (active and sham rTMS treatment), washout period ≥ 1 month between the testing weeks. rTMS treatment sessions will take place twice daily on days 1-3 of each test week. Active treatment will be delivered at 90% resting motor threshold intensity. Stimulation will be administered at 20 Hz with 25 stimulation trains of 30 stimuli each with an inter-train interval of 30 sec at equivalent stimulation parameters as those used in our pilot trial. Stimulation Site: Advanced neuronavigation methods will be used to target rTMS to the dorsolateral prefrontal cortex following a T1 weighted MRI scan.
Subjects will undergo two testing weeks (active and sham rTMS treatment) administered in a randomized order, to which both experimenter and participant will be blind. There will be a washout period of at least one month between the testing weeks to ensure that any changes in cortical function induced by rTMS have returned to baseline. rTMS treatment sessions will take place twice daily on days 1-3 of each test week. Sham Condition: A single-wing tilt rTMS coil position producing somatic sensation (contraction of scalp muscles) with minimal direct brain effects will be used (same stimulation parameters and site as active condition).
Eligibility Criteria
You may qualify if:
- Have a Full Scale IQ ≥ 80 as determined by the Shipley-2 which provides an estimate of pre-morbid intelligence
- Be non-treatment seeking smokers;
- Have a score greater than 5 on the Fagerstrom Test of Nicotine Dependence (FTND), a 5-item multiple choice questionnaire which assesses nicotine dependence
- Report smoking of at least 10 cigarettes per day using a self-report 7-day timeline follow-back
- Have an expired breath CO level \>10ppm
- Be able to provide informed consent.
- Meet SCID for DSM-IV diagnostic criteria for schizophrenia or schizoaffective disorder
- Be in stable remission from positive symptoms of psychosis as judged by psychiatric evaluation and a PANSS total score \<70
- Be receiving a stable dose of antipsychotic mediation(s) for at least one month.
- Do not meet SCID for DSM-IV criteria for any current or past psychiatric disorder except for past major depression if it has been in remission for a minimum of one year
- Not taking any psychotropic medications
You may not qualify if:
- Meet criteria for abuse or dependence of alcohol or illicit substances within the past 3 months (with the exception of nicotine dependence or caffeine)
- Use of nicotine replacement or tobacco products other than cigarettes
- Concomitant medical illness (including unstable or other presentations thought by investigators to compromise study participation, e.g. diabetes mellitus, hypothyroidism or acute/chronic renal insufficiency) or neurological illness including a history of seizures or a first-degree relative with a history of a seizure disorder
- Be pregnant or planning to become pregnant
- Metallic implants.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tony P George, M.D.
Centre for Addiction and Mental Health, Schizophrenia Program, Toronto, ON, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD
Study Record Dates
First Submitted
January 25, 2012
First Posted
February 1, 2012
Study Start
April 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
September 9, 2015
Record last verified: 2015-09