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SchizophreniarTMSsmokelabNCT01523730

Effects of rTMS on Cigarette Smoking and Cognition in Schizophrenia

A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Schizophrenia and Nicotine Addiction, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Schizophrenia, Nicotine Addiction
What is being tested?
Repetitive Transcranial Magnetic Stimulation (rTMS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
1 siteCanada
Study dates
Apr 2012to Sep 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
Show all 17Show fewer
  • 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
  • General Exclusion Criteria:
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M5T 1R8

Other trials in Canada

About this study

Official title: Effects of Repetitive Transcranial Magnetic Stimulation on Cigarette Smoking and Cognitive Function in Smokers With and Without Schizophrenia

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.

Being tested
Repetitive Transcranial Magnetic Stimulation (rTMS), Sham Repetitive Transcranial Stimulation (rTMS)
Keywords
Schizophrenia, Nicotine, Transcranial Magnetic Stimulation, Cognition, EEG
Medical subject headings
Schizophrenia, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Repetitive Transcranial Magnetic Stimulation (rTMS)Device

    Also called Brain stimulation

    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.

  • Sham Repetitive Transcranial Stimulation (rTMS)Device

    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).

Study groups in NCT01523730
Study groupRoleWhat they receive
Repetitive Transcranial Magnetic Stimulation (rTMS)Active comparatorNot described
Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMSPlacebo comparatorNot described
Receives: Device: Sham Repetitive Transcranial Stimulation (rTMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

  1. Cigarette withdrawal using the Minnesota Nicotine Withdrawal Scale (MNWS)

    Withdrawal will be assessed using the MNWS on which subjects self-report nicotine withdrawal symptoms including nicotine craving, irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depressed mood, and insomnia on a 5-point scale of 1 (none) to 5 (severe). Note: The internal consistencies and test-retest reliability of the MNWS, TQSU and FTND in schizophrenia are comparable to those observed in controls.

    Measured: 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)

  2. Expired breath carbon monoxide (CO) levels

    Expired Breath CO (in parts per million; ppm) will be used to biochemically verify smoking status.

    Measured: 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)

  3. Plasma nicotine/cotinine levels

    Plasma nicotine and cotinine levels will provide and objective measurement of cigarette smoking. Assays will be performed by the CAMH Clinical Laboratory using GC/MS/MS procedures which have been adapted from published procedures.

    Measured: 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)

  4. Continuous Performance Test-X (CPT-X)

    The CPT-X is designed to measure sustained attention and response inhibition. Participants press the space bar as quickly as possible after each letter is presented except when the letter 'X' is presented. Common measures reported include % Hits, % Omissions, % Commissions, Reaction Time, Reactions Time Variability and an Attentional Index (d') Duration: 15 minutes

    Measured: 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. N-back

    The N-back is designed to measure working memory (WM). This task requires continuous upgrades of the memory store and is suited to studying varying levels of working memory load. Task-load will be parametrically manipulated by varying the interval between targets requiring responses (i.e., 1-back, 3-back) according to previously published methods. The dependent variables of interest will include the average performance and reaction times. Duration:45 minutes.

    Measured: 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)

  6. Spatial Delayed Response (SDR)

    The SDR is designed to measure visuospatial working memory (VSWM). Subjects focus on a central fixation cross on a computer screen. While fixated (staring at the cross), a dot-shaped cue flashes in one of 32 possible locations towards the outer edge of the screen. Then a delay period occurs (5, 15 or 30 seconds). After the delay, the fixation cross returns and the subjects must point on the computer screen where they remember seeing the dot cue. Results are reported as the averaged "distance from target" in cm for the 10 trials at each delay condition. Duration: 15 minutes.

    Measured: 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)

  7. EEG recording during performance of N-back Task

    EEG recording during performance of N-back Task:

    EEG data will be collected using the methods reported in by our lab. A 64-electrode cap and Synamps2 DC-coupled EEG system (Compumedics) will be used. Evoked γ-power from the frontal electrodes will be measured while the participants complete the N-back task.

    Measured: 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)

  8. Hopkins Verbal Learning Test Revised (HVLT-R)

    The HVLT measures verbal learning and memory. The HVLT-R is a verbal list-learning test designed to measure the acquisition of new verbal information using a 12-item word list.Duration: 10 minutes.

    Measured: 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)

  9. Smoking Topography

    Smoking patterns will be assessed by measuring aspects of smoking topography (using the CReSS system) such as latency to puff, puff frequency, puff volume, puff duration, inter-puff interval, depth of inhalation and inter-cigarette interval which are postulated to be in vivo measures of smoking reinforcement.The CReSS calculates and stores a number of measures including total number of puffs smoked per session, total puff volume per cigarette, puffs per cigarette, duration of inter-puff interval, average maximum puff velocity, average puff volume and average puff duration.

    Measured: Week 1 and 2: At baseline, day 2 when smoking as usual and following over-night smoking abstinence day 3

  10. Spontaneous smoking

    Spontaneous Smoking will be assessed by self-report using timeline followback (TLFB) methods.

    Measured: Week 1 and 2: Pre- and post rTMS/sham treatment at baseline day 1 and 2 when smoking as usual) and following over-night smoking abstinence day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01523730
Sponsor's protocol ID
rTMSlab#126/2011
Acronym
rTMSsmokelab
Status last verified
Sep 2015
First submitted
25 Jan 2012
Last updated
9 Sep 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Schizophrenia and Nicotine Addiction, run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cigarette craving as assessed by Tiffany Questionnaire for Smoking Urges (TQSU) (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01523730.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.

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