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| Name | Class |
|---|---|
| National Health Research Institutes, Taiwan | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| theta burst stimulation | Experimental | 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. |
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| Sham arm | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent theta burst transcranial magnetic stimulation (iTBS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale (Taiwanese version) | Respondents will specify their level of craving from none to extreme on a 100 mm line (score: 0-10) in each questionnaires, and there are nine questionnaires related to craving. | Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| The Beck depression inventory (Taiwanese version BDI) | The Beck depression inventory (Taiwanese version BDI) will be applied to evaluate the depression during the period of methamphetamine abstinence. (Total score: 0-63) | Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16 |
| The Beck anxiety inventory (Taiwanese version BAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng-Che Chen, MD, MSc | Contact | 0972654912 | hugocc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Cheng-Che Chen, MD, MSc | Physician, Department if Psychiatry, National Taiwan University Hospital Hsin-Chu branch | Principal Investigator |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D019969 | Amphetamine-Related Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
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| Sham stimulation | 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. |
|
The Beck anxiety inventory (Taiwanese version BAI) will be applied to evaluate the anxiety during the period of methamphetamine abstinence. (Total score: 0-63) |
| Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16 |
| Cognitive function | Continuous performance test was developed by Rosvold and designed as a computerized test of cognitive function.The outputs include hit rates, correct percentages, and answer time for each item. Generally, higher correct percentage with shorter answer time mean better attention. | Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16 |
| Tolerance | The respondents will specify five physical symptoms which might related to rTMS intervention (Yes/No: headache, local pain/discomfort, head/face pain/discomfort, seizure, hearing loss/ear ache) | Post intervention everytime (8 times total) |
| blood biomarkers | Three biomarker reflecting neuron inflammation or neuron damage will be measured using blood samples, including C-C Motif chemokine ligand 11, neurofilament light chain and exosomal RNA to explore the possible mechanism of iTBS. | Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16 |
| Electroencephalography | The EEG will be perform to collect the parameters across broad brain regions to transform into subsequent information of functional connectivity, including phase locking value (PLV) across all electrodes for delta, theta, alpha, and beta frequency bands. | Baseline(Week 0), Week 4 |
| D064419 |
| Chemically-Induced Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |