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Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation (TMS-GD)

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ClinicalTrials.gov Identifier: NCT03669315
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Stefano Pallanti, CNS Onlus

Brief Summary:
In this project the investigators propose a randomized double-blind placebo-controlled design in which 40 patients with GD will receive active or sham cTBS to the pre-SMA for 2 weeks. The investigators will combine TMS, multimodal structural and functional MRI and behavioral measures in order to identify circuit-level mechanisms of action and therapeutic targets (connectivity changes that explain clinical improvement) and assess the efficacy of TMS in modulating inhibitory control and symptom severity in this population.

Condition or disease Intervention/treatment Phase
Gambling Disorder Device: Transcranial Magnetic stimulation Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After selection and enrollment, participants will be screened at baseline with MRI and a complete diagnostic and clinical assessment, described in the following corresponding sections. Using a placebo-controlled double-blind design patients will be randomized to receive active or placebo cTBS.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Outcome assessor, investigators and participants will be blinded to the type of treatment (active TMS or Placebo)
Primary Purpose: Treatment
Official Title: Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation
Actual Study Start Date : May 20, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active cTBS treatment
Active cTBS will be administered with a Magventure MagPro Stimulator R30 using a butterfly coil. TBS consists of bursts of 3 pulses separated by 20ms (i.e. 50 Hz), with each triplet being repeated every 200 ms (i.e. 5 Hz). Stimulus intensities will be set at 80% of AMT. The investigators will use 2 trains of 600 pulses each separated by 1 minute (a total of 1200 pulses).
Device: Transcranial Magnetic stimulation
Neuromodulation tool

Sham Comparator: Sham cTBS treatment
Sham cTBS will be administered with a Magventure MagPro Stimulator R30 using a butterfly sham coil. The same active cTBS configuration will be used.
Device: Transcranial Magnetic stimulation
Neuromodulation tool




Primary Outcome Measures :
  1. cTBS effects on gambling symptoms change [ Time Frame: Baseline - Day 10 (after 10 cTBS sessions) - after 1 month follow-up ]
    cTBS effects on gabling symptoms severity assessed through the PG-Y-BOCS (Yale-Brown Obsessive-Compulsive Scale modified for Pathological Gambling). Range from: 0-40 (higher values=worse symptoms)

  2. cTBS effects on gambling symptoms change [ Time Frame: Baseline - Day 10 (after 10 cTBS sessions) - after 1 month follow-up ]
    cTBS effects on gabling symptoms severity assessed through the GUQ (Gambling Urges Questionnaire). Range from: 0-60 (higher values=worse symptoms)


Secondary Outcome Measures :
  1. Acute mechanism of action [ Time Frame: Day 1 ]
    Functional MRI assessment

  2. Chronic mechanism of action [ Time Frame: Day 10 ]
    Functional MRI assessment



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. DSM-5 diagnosis of Gambling Disorder
  2. Age between 18 and 65 years

Exclusion Criteria:

  1. any additional current psychiatric comorbidity, except for nicotine addiction;
  2. a lifetime DSM-5 diagnosis of schizophrenia or other psychotic syndromes, substance dependence or substance abuse, including alcohol, bipolar I or II disorder, mental disorder due to a general medical condition;
  3. serious suicide risk;
  4. illness duration less than two years;
  5. hospitalization in the last 6 months;
  6. the inability to receive TMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives);
  7. any major medical disease;
  8. pregnancy or nursing of an infant;
  9. the inability or refusal to provide written informed consent.

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): NCT03669315


Locations
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Italy
CNSOnlus, Institute of Neuroscience Recruiting
Florence, Italy, 50100
Contact: Stefano Pallanti, M.D.    55 587889 ext 0039    stefanopallanti@yahoo.it   
Sponsors and Collaborators
CNS Onlus

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Responsible Party: Stefano Pallanti, Professor, CNS Onlus
ClinicalTrials.gov Identifier: NCT03669315     History of Changes
Other Study ID Numbers: TMS-GD
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Keywords provided by Stefano Pallanti, CNS Onlus:
Gambling Disorder
Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
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Disease
Gambling
Pathologic Processes
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders