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Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder

Primary Purpose

Craving, Depression, Anxiety, Amphetamine Addiction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intermittent theta burst transcranial magnetic stimulation (iTBS)
Sham stimulation
Sponsored by
National Taiwan University Hospital Hsin-Chu Branch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Craving focused on measuring Addiction, amphetamine, non-invasive theta burst stimulation

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    theta burst stimulation

    Sham arm

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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)
    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)
    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.
    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)
    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.
    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.

    Full Information

    First Posted
    April 27, 2022
    Last Updated
    September 7, 2022
    Sponsor
    National Taiwan University Hospital Hsin-Chu Branch
    Collaborators
    National Health Research Institutes, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05535101
    Brief Title
    Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder
    Official Title
    Exploration of Non-invasive Theta Burst Stimulation in Patients With Methamphetamine Use Disorder: Efficacy and Mechanism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital Hsin-Chu Branch
    Collaborators
    National Health Research Institutes, Taiwan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Craving, Depression, Anxiety, Amphetamine Addiction
    Keywords
    Addiction, amphetamine, non-invasive theta burst stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    theta burst stimulation
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Sham arm
    Arm Type
    Sham Comparator
    Arm Description
    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
    Intervention Name(s)
    Intermittent theta burst transcranial magnetic stimulation (iTBS)
    Intervention Description
    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
    Intervention Name(s)
    Sham stimulation
    Intervention Description
    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 Measure Information:
    Title
    Visual analogue scale (Taiwanese version)
    Description
    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.
    Time Frame
    Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
    Secondary Outcome Measure Information:
    Title
    The Beck depression inventory (Taiwanese version BDI)
    Description
    The Beck depression inventory (Taiwanese version BDI) will be applied to evaluate the depression during the period of methamphetamine abstinence. (Total score: 0-63)
    Time Frame
    Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
    Title
    The Beck anxiety inventory (Taiwanese version BAI)
    Description
    The Beck anxiety inventory (Taiwanese version BAI) will be applied to evaluate the anxiety during the period of methamphetamine abstinence. (Total score: 0-63)
    Time Frame
    Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
    Title
    Cognitive function
    Description
    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.
    Time Frame
    Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
    Title
    Tolerance
    Description
    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)
    Time Frame
    Post intervention everytime (8 times total)
    Title
    blood biomarkers
    Description
    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.
    Time Frame
    Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
    Title
    Electroencephalography
    Description
    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.
    Time Frame
    Baseline(Week 0), Week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ranged 20-65. Diagnosis as amphetamine use disorder by clinical psychiatrist according to DSM-V Exclusion Criteria: Major disorders other than substance use disorders in Diagnostic and Statistics Manual-5 (e.g. Schizophrenia, organic brain syndrome, and bipolar disorders). Epilepsy, head trauma, migraine, cardiovascular comorbidity, atypical parkinsonian disorder patients with heart pacemakers, implanted drug delivery aids, artificial electronic ears, implantable defibrillators, and/or implanted nerve stimulators, and near the implants mentioned above. patients with metal implants above the chest. people who have damaged skin in areas of the patient's body that receive stimulation. patients with multiple sclerosis. patients who have extensive ischemic scarring. pregnant women. patients with a family history of spasms/epilepsy patients taking medications that may lower the seizure threshold. patients with severe sleep disorders related to previous rTMS treatment. patients with severe heart disease patients with intracranial stress caused by uncontrollable migraines. people who have been evaluated by a physician as unfit to participate in clinical trials.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cheng-Che Chen, MD, MSc
    Phone
    0972654912
    Email
    hugocc@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cheng-Che Chen, MD, MSc
    Organizational Affiliation
    Physician, Department if Psychiatry, National Taiwan University Hospital Hsin-Chu branch
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder

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