Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder

September 7, 2022 updated by: National Taiwan University Hospital Hsin-Chu Branch

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cheng-Che Chen, MD, MSc
  • Phone Number: 0972654912
  • Email: hugocc@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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_COMPARATOR: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (Taiwanese version)
Time Frame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Beck depression inventory (Taiwanese version BDI)
Time Frame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
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)
Time Frame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
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
Time Frame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
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
Time Frame: Post intervention everytime (8 times total)
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
Time Frame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
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
Time Frame: Baseline(Week 0), Week 4
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital Hsin-Chu Branch

Collaborators

National Health Research Institutes, Taiwan

Investigators

  • Principal Investigator: Cheng-Che Chen, MD, MSc, Physician, Department if Psychiatry, National Taiwan University Hospital Hsin-Chu branch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2022

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (ACTUAL)

September 10, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2022

Last Update Submitted That Met QC Criteria

September 7, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111-019-F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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