Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation

NCT03669315 | Recruiting Phase 3 FDA Device

• 1 other identifier: TMS-GD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gambling Disorder

Keywords

Gambling Disorder; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (2)

• cTBS effects on gambling symptoms change

  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)

  Baseline - Day 10 (after 10 cTBS sessions) - after 1 month follow-up

• cTBS effects on gambling symptoms change

  cTBS effects on gabling symptoms severity assessed through the GUQ (Gambling Urges Questionnaire). Range from: 0-60 (higher values=worse symptoms)

  Baseline - Day 10 (after 10 cTBS sessions) - after 1 month follow-up

Secondary Outcomes (2)

• Acute mechanism of action

  Day 1

• Chronic mechanism of action

  Day 10

Study Arms (2)

Active cTBS treatment

ACTIVE COMPARATOR

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

Sham cTBS treatment

SHAM COMPARATOR

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

Interventions

Transcranial Magnetic stimulation DEVICE

Neuromodulation tool

Active cTBS treatment; Sham cTBS treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-5 diagnosis of Gambling Disorder
• Age between 18 and 65 years

You may not qualify if:

• any additional current psychiatric comorbidity, except for nicotine addiction;
• 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;
• serious suicide risk;
• illness duration less than two years;
• hospitalization in the last 6 months;
• the inability to receive TMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives);
• any major medical disease;
• pregnancy or nursing of an infant;
• the inability or refusal to provide written informed consent.

Sponsors & Collaborators

• CNS Onlus: lead

Study Sites (1)

CNSOnlus, Institute of Neuroscience

Florence, 50100, Italy

RECRUITING

MeSH Terms

Conditions

Gambling

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessor, investigators and participants will be blinded to the type of treatment (active TMS or Placebo)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 13, 2018
• Study Start: May 20, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)