Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder

NCT ID: NCT05535101

Last Updated: 2022-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

theta burst stimulation

Those participants to receive 1-3 sessions in a single day at an interval of 15 minutes(at least), and 5 high-frequency iTBS sessions per week in total four weeks. Each session: 600-900 pulses with 120-100% resting motor threshold.

Group Type: EXPERIMENTAL

Intermittent theta burst transcranial magnetic stimulation (iTBS)

Intervention Type: DEVICE

The amphetamine users will undergo a one-month iTBS intervention. From Week 1 to Week 4, subjects will be treated five times a week.

Sham arm

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.

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ranged 20-65.

2. Diagnosis as amphetamine use disorder by clinical psychiatrist according to DSM-V

Exclusion Criteria

1. Major disorders other than substance use disorders in Diagnostic and Statistics Manual-5 (e.g. Schizophrenia, organic brain syndrome, and bipolar disorders).

2. Epilepsy, head trauma, migraine, cardiovascular comorbidity, atypical parkinsonian disorder

3. patients with heart pacemakers, implanted drug delivery aids, artificial electronic ears, implantable defibrillators, and/or implanted nerve stimulators, and near the implants mentioned above.

4. patients with metal implants above the chest.

5. people who have damaged skin in areas of the patient's body that receive stimulation.

6. patients with multiple sclerosis.

7. patients who have extensive ischemic scarring.

8. pregnant women.

9. patients with a family history of spasms/epilepsy

10. patients taking medications that may lower the seizure threshold.

11. patients with severe sleep disorders related to previous rTMS treatment.

12. patients with severe heart disease

13. patients with intracranial stress caused by uncontrollable migraines.

14. people who have been evaluated by a physician as unfit to participate in clinical trials.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheng-Che Chen, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Physician, Department if Psychiatry, National Taiwan University Hospital Hsin-Chu branch

Central Contacts

Cheng-Che Chen, MD, MSc

Role: CONTACT

hugocc@gmail.com

0972654912

Other Identifiers

111-019-F

Identifier Type: -

Identifier Source: org_study_id