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Theta burst Transcranial Magnetic Stimulation for Methamphetamine use disorder (TARTAN)

Theta burst Transcranial Magnetic Stimulation (TMS) for Methamphetamine use disorder– A feasibility study to inform a multi-site Randomised Control Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000762752
Acronym
TARTAN
Enrollment
14
Registered
2022-05-27
Start date
2022-05-23
Completion date
2023-03-30
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial will examine the use of Transcranial Magnetic Stimulation (TMS) in outpatient settings for moderate to severe MA dependance. Specifically protocols of TMS involving intermittent Theta Burst TMS (iTBS) to the left Dorso Lateral Pre Frontal Cortex (DLPFC), followed by continuous TBS (cTBS) to the left Orbito Frontal Cortex (OFC). Methamphetamine (MA) use and dependance is widespread with significant harms to individuals and others, but limited treatment options of modest effectiveness are available. TMS/TBS are non-invasive treatments that place a coil on the scalp to create magnetic fields that excite/stimulate cells in specific areas of the brain. It is is a promising treatment for substance dependance, with studies documenting positive outcomes for cravings in tobacco, alcohol and cocaine dependance. Importantly, the safety of TMS/TBS protocols have been extensively documented with over a decade of use in a wide variety of clinical settings including depression. There is expert agreement of the safety of TMS /TBS for substance use disorders.

Interventions

Stimulation Localisation: Scalp locations at which the TMS coil will be placed will be determined using standard EEG 10-20 system landmarks. These two locations are: Intermittent TBS (iTBS) to the left Dorso Lateral Pre Frontal Cortex (DLPFC): Treatment will be localised at the F3 EEG site which corresponds to left DLPFC. Continuous TBS (cTBS) to the left Orbito Frontal Cortex (OFC): Treatment will be localised at the FP1 EEG site which corresponds to the left OFC. Provision of intervention

Stimulation Localisation: Scalp locations at which the TMS coil will be placed will be determined using standard EEG 10-20 system landmarks. These two locations are: Intermittent TBS (iTBS) to the left Dorso Lateral Pre Frontal Cortex (DLPFC): Treatment will be localised at the F3 EEG site which corresponds to left DLPFC. Continuous TBS (cTBS) to the left Orbito Frontal Cortex (OFC): Treatment will be localised at the FP1 EEG site which corresponds to the left OFC. Provision of intervention TBS will be administered with a TGA registered TMS device (Neuro-MSD and Angulated Fig8 Coil). Prior to the commencement of TBS treatment, single pulse TMS will be used to measure the resting motor thresholds (RMT) for the abductor pollicis brevis (APB) in all subjects using standard published methods. The RMT is used to determine the intensity of the TBS treatment for each individual participant Stimulation Parameters: TBS intervention Protocol A. First. iTBS will be delivered at the Left DLPFC(F3) as 3-pulse 50-Hz bursts applied at 5 Hz (i.e. 50 Hz burst of 3 pulses delivered every 200ms) with a 2-second train of TBS repeated every 10 seconds (i.e. 2 seconds of TBS followed by an 8 second rest). Total number of pulses is 600. Each TBS treatment session will take approximately 3 minutes. During the initial treatment sessions, the amplifier output will be escalated (over 30 sec) from 70% to 110% RMT to enhance tolerability. For clients who experience discomfort and are not able to comfortably tolerate increases in intensity, the level will be maintained at the maximally tolerable level. Participants will be withdrawn if they are unable to tolerate treatment at a minimum 70% of the RMT at the end of the 3rd day of treatment. Protocol B. Second: Following this, cTBS will be delivered at the left OFC: A single train of cTBS will be applied over the left frontal pole (Fp1) (3 pulse 50 Hz bursts applied at 5Hz, 15 pulses/sec, 600 pulses/train; 100% RMT. During the cTBS procedure the amplifier output will be escalated during the first train (over 30 sec) from 70% to 100% RMT to enhance tolerability. For clients who experience discomfort and are not able to comfortably tolerate this intensity, the level will progressively be decreased until a comfortable intensity is reached. Participants will be withdrawn if they are unable to tolerate treatment at 70% of the RMT at the end of the 3rd day of treatment. Then there is a 10 minute interval and Protocol A and B are repeated. Then protocol A and protocol B will be repeated for another two cycles in a treatment day with 10 minute intervals after protocol B (that is three cycles of Protocol A and B in a treatment day) if tolerated. TBS will be provided on three days of each week for a total of four weeks for each participant (that is a total of 12 sessions of TMS over four weeks). Medical specialists (Addiction Psychiatrists and Addiction Medicine Specialists) will screen patients and establish treatment parameters for each patient and do the first treatment. Clinical research officers under the supervision of medical specialists will deliver subsequent interventions. All will have a certificate of accreditation by Neurocare for delivery of TMS (course: rTMS for Depression, OCD & New Developments). Location of the intervention: Clinical Research rooms, Level 3, Newcastle Community Health Centre, 670 Hunter Street, Newcastle, NSW 2300. Counselling: All participants will be offered standard care for MA use disorders, involving psychosocial counselling (of approximately 50 minutes) for the duration of the study and referral to appropriate services post study as clinically indicated. Importantly, study related counselling sessions will provide support to participants through psychoeducation into the neurocircuitry of MA use disorder, relapse prevention for MA dependence and TMS treatment adherence. Counselling sessions will be offered face to face or by telehealth or telephone as requested. Clients will be offered one counselling session per week during the 4 weeks of treatment. Counselling will be performed by a trained HNELHD Drug and Alcohol Clinical Services counsellor independent of the study. Counselling will be standardised using an established protocol for Cognitive Behavioural Therapy for MA use disorder, and one counsellor independent of the TMS research team will deliver the sessions as per the standardised counselling protocol. Data. Every client will have an individual case record where adherence to each of the 12 TMS sessions is recorded (including partial treatment or missed sessions recorded), and adherence to the four counselling sessions will be recorded.

Sponsors

Hunter New England Local Health District Drug and Alcohol Clinical Services
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

• Aged 18-65 years • Meets DSM 5 criteria for moderate to severe MA use disorder • Current MA past month use • Able to give written informed consent • Be willing and able to comply with the requirements of the study

Exclusion criteria

• Other psychoactive substance use requiring withdrawal management pharmacotherapy in the 28 days preceding eligibility screening (e.g. alcohol withdrawal requiring diazepam) • Current pharmacotherapy for amphetamine use disorder (e.g. dexamphetamine) in the 28 days preceding eligibility screening. • Current diagnosis of bipolar disorder, schizoaffective disorder, schizophrenia, that is deemed by research team psychiatrists not to have been drug-induced. Psychotic disorder not associated with drug use per DSM 5 criteria. Psychosis not otherwise specified (NOS), in remission, or drug-induced psychotic episodes are not exclusion criteria since these may be related to methamphetamine misuse. • Severe uncontrolled medical condition, diagnosis of neurological disorder or neurocognitive disorder. Prior neurosurgical procedure. • Contraindications to TMS (e.g. patients with epilepsy or seizure disorder, patients with implanted ferromagnetic equipment in their face or skull near the stimulation target, Cochlear implants, metal implant or electronic devices in the head, brain aneurysm clips/coils, VNS, pacemakers, deep brain stimulation, VP shunts, brain or neck stents, epilepsy, medical pump, hearing disorder, recent head injury). • Current or planned pregnancy • History of ECT treatment within the past three months. • History of any previous TMS treatment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 8, 2026