Pathological GamblerNCT02552524
Effect of rTMS in Pathological Gamblers
A study of Pathological Gambler, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The gambling problem is characterized by a loss of control and an excessive focus on the gambling practice. Currently, the treatment of pathological gamblers is often complex and multidimensional, it notably includes psychological techniques including cognitive behavioral therapy and the use of psychotropic drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathological Gambler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of pathological gambling (DSM IV criteria)
- First-time consultants.
- Without psychotropic treatment or treatment with a stable and unchanged for over a month.
Who cannot join
- Presence of ferromagnetic material or devices implanted neurostimulation in close contact with the coil
- Pregnant women and patients with hearing disorders
- Personal history of epilepsy (untreated or poorly balanced)
- Focal brain injury, whatever its origin (vascular, traumatic, tumor or infectious)
- History of head trauma with loss of consciousness,
- Administration of drugs or substances lowering the seizure threshold
Show all 12Show fewer
- Sleep deprivation, jet lag, or drug withdrawal.
- Participants with a problem of uncorrected visual acuity.
- Other current addiction (except tobacco, for reasons of feasibility).
- Current Psychiatric comorbidity
- Treatment psychotropic introduced or changed for less than a month.
- Subjects with atrial fibrillation, with a pacemaker and / or receiving antiarrhythmic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effect of an Active rTMS Session in Pathological Gamblers: Impact on Craving and Severity of These Behaviors
The gambling problem is characterized by a loss of control and an excessive focus on the gambling practice. Currently, the treatment of pathological gamblers is often complex and multidimensional, it notably includes psychological techniques including cognitive behavioral therapy and the use of psychotropic drugs.
In pathological gambling and addictions, craving (or urge to play) and loss of control are two essential clinical elements. The neurobiological level, they are associated with a dysfunction of dorsolateral prefrontal cortex (DLPFC) (Goldstein et al, 2001, Volkow and Goldstein, 2002).
One therapeutic avenues explored in addictions is repeated transcranial magnetic stimulation (rTMS).
Read the detailed description
Patients included in this study will have:
- An anatomical brain MRI (30 minutes).
- Two 20 minute sessions of rTMS (placebo and active) of the left DLPFC, at the frequency of 10 Hz.
- Visual Analogue Scale measuring their desire to gamble before and after a gambling video and test measuring their gambling behavior during the last 7 days (PG-YBOCS).
- Cognitive tests, to be carried out on a computer before and immediately after rTMS sessions.
- Recording heart rate variability (HRV) to measure the autonomic nervous system (ANS) activity
As it is a pilot study, the investigators don't have sufficient data to calculate statistical power and number of participants. The investigators based on previous studies evaluating one rTMS session on craving in SUD and used a crossover design to generate greater power.
- Conditions
- Pathological Gambler
- Being tested
- rTMS active then rTMS placebo, rTMS placebo then rTMS active
- Keywords
- pathological gambling, rTMS, cognitive tests, autonomic nervous system, craving
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS active then rTMS placeboDevice
A 20 minute session of rTMS active at the frequency of 10 Hz then, 7 days later, a 20 minute session of rTMS placebo
rTMS placebo then rTMS activeDevice
A 20 minute session of rTMS placebo then, 7 days later, a 20 minute session of rTMS at the frequency of 10 Hz
| Study group | Role | What they receive |
|---|---|---|
| rTMS active then rTMS placebo | Experimental | A 20 minute session of rTMS active at the frequency of 10 Hz then, 7 days later, a 20 minute session of rTMS placebo (rTMS active then rTMS placebo).
Patient will also have cognitive tests before and after rTMS session and HRV recording during visit. Receives: Device: rTMS active then rTMS placebo |
| rTMS placebo then rTMS active | Experimental | A 20 minute session of rTMS placebo then, 7 days later, a 20 minute session of rTMS active at the frequency of 10 Hz (rTMS placebo then rTMS active).
Patient will also have cognitive tests before and after rTMS session and HRV recording during visit Receives: Device: rTMS placebo then rTMS active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing cue-induced craving
Scores on visual analog scales assessing craving just after a gambling video
Measured: After the session of rTMS (Day 2)
Secondary outcomes (3)
Game behavior
Scores at the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS) (Pallanti et al., 2005)) assessing the severity of gambling behavior over the past week
Measured: Day 2
Cognitive tests
Reaction time and number of errors at Go-Nogo, Flexibility task and Iowa Gambling test
Measured: Day 2
ANS activity
Indice HF, LF and LF/HF, heart rate; during gambling video
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startDec 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pathological GamblerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurelia GAY, MD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552524
- Sponsor's protocol ID
- 1201091
- Other IDs
- 2012-A01013-40
- Status last verified
- Jun 2016
- First submitted
- 11 Sep 2015
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gay A, Boutet C, Sigaud T, Kamgoue A, Sevos J, Brunelin J, Massoubre C. A single session of repetitive transcranial magnetic stimulation of the prefrontal cortex reduces cue-induced craving in patients with gambling disorder. Eur Psychiatry. 2017 Mar;41:68-74. doi: 10.1016/j.eurpsy.2016.11.001. Epub 2017 Feb 3.
PubMed 28049084
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of an Active rTMS Session in Pathological Gamblers: Impact on Craving and Severity of These Behaviors
- ClinicalTrials.gov ID
- NCT02552524
- Acronym / sponsor ID
- 1201091
- Conditions
- Pathological Gambler
- Keywords
- pathological gambling, rTMS, cognitive tests, autonomic nervous system, craving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The gambling problem is characterized by a loss of control and an excessive focus on the gambling practice. Currently, the treatment of pathological gamblers is often complex and multidimensional, it notably includes psychological techniques including cognitive behavioral therapy and the use of psychotropic drugs.
In pathological gambling and addictions, craving (or urge to play) and loss of control are two essential clinical elements. The neurobiological level, they are associated with a dysfunction of dorsolateral prefrontal cortex (DLPFC) (Goldstein et al, 2001, Volkow and Goldstein, 2002).
One therapeutic avenues explored in addictions is repeated transcranial magnetic stimulation (rTMS).
Detailed description
Patients included in this study will have:
- An anatomical brain MRI (30 minutes).
- Two 20 minute sessions of rTMS (placebo and active) of the left DLPFC, at the frequency of 10 Hz.
- Visual Analogue Scale measuring their desire to gamble before and after a gambling video and test measuring their gambling behavior during the last 7 days (PG-YBOCS).
- Cognitive tests, to be carried out on a computer before and immediately after rTMS sessions.
- Recording heart rate variability (HRV) to measure the autonomic nervous system (ANS) activity
As it is a pilot study, the investigators don't have sufficient data to calculate statistical power and number of participants. The investigators based on previous studies evaluating one rTMS session on craving in SUD and used a crossover design to generate greater power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS active then rTMS placebo | Experimental | Device: rTMS active then rTMS placeboA 20 minute session of rTMS active at the frequency of 10 Hz then, 7 days later, a 20 minute session of rTMS placebo (rTMS active then rTMS placebo). Patient will also have cognitive tests before and after rTMS session and HRV recording during visit. |
| rTMS placebo then rTMS active | Experimental | Device: rTMS placebo then rTMS activeA 20 minute session of rTMS placebo then, 7 days later, a 20 minute session of rTMS active at the frequency of 10 Hz (rTMS placebo then rTMS active). Patient will also have cognitive tests before and after rTMS session and HRV recording during visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a diagnosis of pathological gambling (DSM IV criteria)
- First-time consultants.
- Without psychotropic treatment or treatment with a stable and unchanged for over a month.
Key exclusion criteria (12 listed)
- Presence of ferromagnetic material or devices implanted neurostimulation in close contact with the coil
- Pregnant women and patients with hearing disorders
- Personal history of epilepsy (untreated or poorly balanced)
- Focal brain injury, whatever its origin (vascular, traumatic, tumor or infectious)
- History of head trauma with loss of consciousness,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMS active then rTMS placeboA 20 minute session of rTMS active at the frequency of 10 Hz then, 7 days later, a 20 minute session of rTMS placebo | Device | rTMS active then rTMS placebo |
| rTMS placebo then rTMS activeA 20 minute session of rTMS placebo then, 7 days later, a 20 minute session of rTMS at the frequency of 10 Hz | Device | rTMS placebo then rTMS active |
Primary outcome
Assessing cue-induced craving
Time frame: After the session of rTMS (Day 2)
Scores on visual analog scales assessing craving just after a gambling video
3 secondary outcomes
Game behavior
Time frame: Day 2
Cognitive tests
Time frame: Day 2
ANS activity
Time frame: Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Derived from this study: PubMed 28049084Gay A, Boutet C, Sigaud T, Kamgoue A, Sevos J, Brunelin J, Massoubre C. A single session of repetitive transcranial magnetic stimulation of the prefrontal cortex reduces cue-induced craving in patients with gambling disorder. Eur Psychiatry. 2017 Mar;41:68-74. doi: 10.1016/j.eurpsy.2016.11.001. Epub 2017 Feb 3.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurelia GAY, MD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pathological Gambler, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 3 inclusion and 12 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 6 Jun 2016. 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 France. 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. 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?
Assessing cue-induced craving (time frame: After the session of rTMS (Day 2)). 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 NCT02552524, which also lists 1 linked publication.
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 6 Jun 2016.