Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05535101
• Other study ID #: 111-019-F
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2022
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: Cheng-Che Chen, MD, MSc
• Phone: 0972654912
• Email: hugocc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amphetamine Addiction
• Amphetamine-Related Disorders
• Behavior, Addictive
• Craving
• Depression, Anxiety

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch	National Health Research Institutes, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	The Beck anxiety inventory (Taiwanese version BAI)	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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