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Transcranial Magnetic stimulation

Phase 3

Gambling Disorder | Unknown | Other |CNS Pharmaceuticals, Inc.|Last Updated: Sep 13, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Transcranial Magnetic stimulation · 1 trial · 1 indication

Phase 3 1
NCT03669315Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst StimulationGambling Disorder
RECRUITING40 Analytics
PHASE3RECRUITING
Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation
Gambling DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

cTBS effects on gambling symptoms change
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)

Secondary Endpoints

Acute mechanism of action
Day 1
Chronic mechanism of action
Day 10
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Active cTBS treatmentACTIVE_COMPARATORActive 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).
Sham cTBS treatmentSHAM_COMPARATORSham cTBS will be administered with a Magventure MagPro Stimulator R30 using a butterfly sham coil. The same active cTBS configuration will be used.

Interventions

NameTypeDescription
Transcranial Magnetic stimulationDEVICENeuromodulation tool
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 sub...

Countries:Italy
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Frequently asked questions about Transcranial Magnetic stimulation

What is Transcranial Magnetic Stimulation used for in Gambling Disorder?

Transcranial Magnetic Stimulation (TMS) is being studied as a treatment for Gambling Disorder. It is an investigational therapy in Phase 3 clinical development, delivered via theta burst stimulation to modulate inhibitory control networks. The therapy is being evaluated in a randomized, double-blind, active-controlled trial in Italy.

What does Transcranial Magnetic Stimulation target?

Transcranial Magnetic Stimulation targets inhibitory control networks in the brain. The therapy uses theta burst stimulation to modulate these networks, which are believed to be involved in the pathophysiology of Gambling Disorder. This mechanism is being studied in a Phase 3 clinical trial.

Who is developing Transcranial Magnetic Stimulation?

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) is the developer of Transcranial Magnetic Stimulation for Gambling Disorder. The company is conducting a Phase 3 clinical trial of this investigational therapy, which is currently recruiting participants in Italy.

What phase is Transcranial Magnetic Stimulation in?

Transcranial Magnetic Stimulation is in Phase 3 clinical development for Gambling Disorder. It is an investigational therapy, not yet approved by regulatory authorities. The ongoing Phase 3 trial is recruiting 40 participants and is active, with no completed trials to date.

What clinical trials is Transcranial Magnetic Stimulation in?

Transcranial Magnetic Stimulation is being evaluated in one Phase 3 clinical trial, NCT03669315, titled 'Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation.' The trial is recruiting 40 participants in Italy, is randomized, double-blind, and active-controlled, and enrolls adults aged 18 years and older.

Is Transcranial Magnetic Stimulation the same as theta burst stimulation?

Transcranial Magnetic Stimulation is delivered using theta burst stimulation in the clinical trial for Gambling Disorder. The trial title specifies theta burst stimulation as the method of administering Transcranial Magnetic Stimulation. The therapy is being studied to modulate inhibitory control networks in the brain.