Transcranial Magnetic Stimulation for Methamphetamine Use Disorder in PLWH

Gopalkumar Rakesh

Status: Enrolling

Conditions: HIV; Methamphetamine Use Disorders

Treatments: Device: continuous theta burst stimulation (cTBS); Device: intermittent theta burst stimulation (iTBS); Device: Sham TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT06830980

100353

Details and patient eligibility

About

The purpose of this study is to learn more about how accelerated theta burst stimulation affects methamphetamine craving and brain activity. Theta burst stimulation is a unique transcranial magnetic stimulation (TMS) paradigm that is efficient and potent.

Full description

The investigators will compare how two theta burst paradigms, intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS), compare with sham TMS in changing methamphetamine craving and brain activity. iTBS, cTBS, and sham TMS will be delivered in an accelerated fashion (two sessions daily, separated by 50 minutes). iTBS will be delivered to the left dorsolateral prefrontal cortex (left dorsolateral prefrontal cortex), and cTBS will be delivered to the frontal pole. A brain MRI scan will be done before and after the iTBS/cTBS/sham TMS sessions. The study involves four visits. Each visit will last three hours. Hence, participants will spend a total of 12 hours in the study.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults in the age group 18-65 years
• Able to read and understand English
• Able to provide informed consent
• Diagnosed with HIV
• History of current or previous Methamphetamine Use Disorder
• Endorse craving for methamphetamine
• Demonstrate an attentional bias for methamphetamine

Exclusion criteria

• Traumatic brain injury
• h/o seizure disorder
• h/o or current diagnosis of schizophrenia
• intracranial metal shrapnel
• previous adverse effects with TMS
• sub-threshold consistency while performing behavioral tasks
• lack of attentional bias to methamphetamine cues
• a positive pregnancy test for female participants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Group 1

Other group

Description:

Group 1 will receive actual TMS (iTBS and cTBS) on days 2 and 3 and sham TMS on day 4.

Treatment:

Device: Sham TMS

Device: intermittent theta burst stimulation (iTBS)

Device: continuous theta burst stimulation (cTBS)

Group 2

Other group

Description:

Group 2 will receive actual TMS (iTBS and cTBS) on days 2 and 4 and sham TMS on day 3.

Treatment:

Device: Sham TMS

Device: intermittent theta burst stimulation (iTBS)

Device: continuous theta burst stimulation (cTBS)

Group 3

Other group

Description:

Group 3 will receive sham TMS on day 2 and actual TMS (iTBS and cTBS) on days 3 and 4.

Treatment:

Device: Sham TMS

Device: intermittent theta burst stimulation (iTBS)

Device: continuous theta burst stimulation (cTBS)