NCT05535101

Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder

Exploration of Non-invasive Theta Burst Stimulation in Patients With Methamphetamine Use Disorder: Efficacy and Mechanism

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Taiwan University Hospital Hsin-Chu Branch · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study aims to apply the intermittent theta burst transcranial magnetic stimulation (iTBS) treatment and evaluate the effect in improving craving, affective symptoms, and cognitive function for those participants in the community with amphetamine use. An electroencephalography and blood biomarkers will also be examined to explore the possible mechanisms.

Detailed description

In this study, participants with amphetamine use will be recruited from psychiatric clinics. They will be randomly assigned to two different transcranial magnetic stimulation groups, the iTBS and sham groups. Those participants to receive 1-3 sessions in a single day at an interval of 15 minutes, and 5 high-frequency iTBS sessions per week in total four weeks. After the completion of the four-week course, the severity of symptoms for the next one month and three months will be tracked.

Conditions

• Craving
• Depression, Anxiety
• Amphetamine Addiction

Interventions

Type	Name	Description
DEVICE	Intermittent theta burst transcranial magnetic stimulation (iTBS)	The amphetamine users will undergo a one-month iTBS intervention. From Week 1 to Week 4, subjects will be treated five times a week.
DEVICE	Sham stimulation	Sham stimulation was delivered using the same protocol as active stimulation, but with the TMS coil rotated by 90 degrees with the edge of the coil touching the scalp.

Timeline

• Start date: 2022-09-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2022-09-10
• Last updated: 2022-09-10