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Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder

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ClinicalTrials.gov Identifier: NCT05535101
Recruitment Status : Not yet recruiting
First Posted : September 10, 2022
Last Update Posted : September 10, 2022
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital Hsin-Chu Branch

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.

Condition or disease Intervention/treatment Phase
Craving Depression, Anxiety Amphetamine Addiction Device: Intermittent theta burst transcranial magnetic stimulation (iTBS) Device: Sham stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Exploration of Non-invasive Theta Burst Stimulation in Patients With Methamphetamine Use Disorder: Efficacy and Mechanism
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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.

  4. 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)

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05535101


Contacts
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Contact: Cheng-Che Chen, MD, MSc 0972654912 hugocc@gmail.com

Sponsors and Collaborators
National Taiwan University Hospital Hsin-Chu Branch
National Health Research Institutes, Taiwan
Investigators
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Principal Investigator: Cheng-Che Chen, MD, MSc Physician, Department if Psychiatry, National Taiwan University Hospital Hsin-Chu branch
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Responsible Party: National Taiwan University Hospital Hsin-Chu Branch
ClinicalTrials.gov Identifier: NCT05535101    
Other Study ID Numbers: 111-019-F
First Posted: September 10, 2022    Key Record Dates
Last Update Posted: September 10, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital Hsin-Chu Branch:
Addiction
amphetamine
non-invasive theta burst stimulation
Additional relevant MeSH terms:
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Amphetamine-Related Disorders
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders