Repetitive dTMS Intervention for Methamphetamine Addiction

NCT04202926 | Completed

• 1 other identifier: TFYuan
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

A growing body of evidence suggests a wide range of brain areas including medial prefrontal cortex (mPFC), dorsolateral prefrontal cortex (DLPFC) and other subcortical regions, such as anterior cingulate cortex (ACC) are critical for regulating cognitive control over decisions and involving in drug related cue processing. Previous studies have demonstrated that transcranial magnetic stimulation (rTMS) over dorsolateral prefrontal cortex reduces craving for meth dependences. Specifically, the H7 coil induces a magnetic field can target mPFC and ACC. In this study, the investigators investigated whether repeated dTMS intervention of medial prefrontal and cingulate cortices in methamphetamine addiction could reduce the subjective craving and improve the cognitive abilities.

Conditions

Methamphetamine-dependence

Keywords

deep transcranial magnetic stimulation; methamphetamine addiction

Outcome Measures

Primary Outcomes (1)

• Changes of Cue-induced craving and ERP

  Subjective craving (cue induced, 0-100 based VAS, craving scale) and drug cue-ERP (P300 etc. measured)

  the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention

Secondary Outcomes (7)

• Changes of cognition: behavioral inhibition

  the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention

• Changes of cognition: working memory

  the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention

• Changes of depression status

  the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention

• Changes of anxiety status

  the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention

• Changes of sleep status

  the day before intervention, 3 weeks after intervention, 1 month after intervention, up to 3 months after intervention

Other Outcomes (1)

• side effect measurements

  every day after each intervention time for the 3 weeks intervention time period

Study Arms (2)

10hz group

EXPERIMENTAL

a high frequency stimulation

Device: real coil

sham group

SHAM COMPARATOR

a sham coil which frequency is 10hz but do not induce stimulation

Device: sham coil

Interventions

real coil DEVICE

active 10Hz with a train of 3s on / 17s off, 50 trains, a total of 1500 pulses

10hz group

sham coil DEVICE

sham 10Hz with a train of 3s on / 17s off, 50 trains, a total of 1500 pulses

sham group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Methamphetamine dependents
• middle school degree or above

You may not qualify if:

• Have contraindications to rTMS (head trauma, epilepsy or history of epilepsy, metal implant etc.)
• psychiatric illnesses
• intellectual impairment (IQ\<90)

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Nanjing Dalianshan Addiction Rehab Center

Nanjing, 210090, China

Location

Related Publications (6)

• Shen Y, Cao X, Tan T, Shan C, Wang Y, Pan J, He H, Yuan TF. 10-Hz Repetitive Transcranial Magnetic Stimulation of the Left Dorsolateral Prefrontal Cortex Reduces Heroin Cue Craving in Long-Term Addicts. Biol Psychiatry. 2016 Aug 1;80(3):e13-4. doi: 10.1016/j.biopsych.2016.02.006. Epub 2016 Feb 12. No abstract available.

  PMID: 26995024 BACKGROUND

• Dunlop K, Hanlon CA, Downar J. Noninvasive brain stimulation treatments for addiction and major depression. Ann N Y Acad Sci. 2017 Apr;1394(1):31-54. doi: 10.1111/nyas.12985. Epub 2016 Feb 5.

  PMID: 26849183 BACKGROUND

• Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21.

  PMID: 31109199 BACKGROUND

• Liu T, Li Y, Shen Y, Liu X, Yuan TF. Gender does not matter: Add-on repetitive transcranial magnetic stimulation treatment for female methamphetamine dependents. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Jun 8;92:70-75. doi: 10.1016/j.pnpbp.2018.12.018. Epub 2018 Dec 31.

  PMID: 30605708 BACKGROUND

• Su H, Zhong N, Gan H, Wang J, Han H, Chen T, Li X, Ruan X, Zhu Y, Jiang H, Zhao M. High frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex for methamphetamine use disorders: A randomised clinical trial. Drug Alcohol Depend. 2017 Jun 1;175:84-91. doi: 10.1016/j.drugalcdep.2017.01.037. Epub 2017 Mar 29.

  PMID: 28410525 BACKGROUND

• Liu Q, Shen Y, Cao X, Li Y, Chen Y, Yang W, Yuan TF. Either at left or right, both high and low frequency rTMS of dorsolateral prefrontal cortex decreases cue induced craving for methamphetamine. Am J Addict. 2017 Dec;26(8):776-779. doi: 10.1111/ajad.12638. Epub 2017 Nov 14.

  PMID: 29134789 BACKGROUND

Study Officials

• Tifei Yuan, PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2019
• First Posted: December 18, 2019
• Study Start: December 30, 2019
• Primary Completion: May 30, 2023
• Study Completion: October 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within twelve months after the trial complete
• Access Criteria: share to health care personnel, patients and the general public.

Locations

CN (1)