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Completed

NCT Number: NCT04202926

Repetitive dTMS Intervention for Methamphetamine Addiction

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Dalianshan Addiction Rehab Center

Nanjing, 210090, China

About this study

The study will be conducted at the drug rehabilitation center in China. The whole procedure includes enrollment, pre-intervention evaluation, intervention (for 3 weeks, 5 times a week, 15 times in total), post-intervention evaluation and one month follow up evaluation.

In enrollment session, participants are recruited according to inclusion criteria.

In the pre-intervention evaluation, firstly, participants need complete a questionnaire to assess their demographic information, drug addiction history and drug abstinence. And then are assigned to either 10Hz group or sham group according to the counterbalance of their basic demographic and drug use information. Then, participants need complete craving, cognitive ability and electroencephalogram (EEG) assessment. For craving assessing, participants are shown a video of methamphetamine usage for 5 minutes, and then rated on the visual analogue scale (0 means completely undesired and 100 means extremely wanting) to report their craving for methamphetamine. For cognitive ability and EEG signal assessing, the whole process is conducted on the computer according to instructions.

In the intervention session, dTMS was administered using a TMS stimulator (Magstim, U.K.) equipped with a unique H-shaped coil design. The H-coil version used in this study was the H7 (Brainsway, Jerusalem, Israel). When placed 4-5 cm anterior to the foot motor cortex and used at 100% of the leg resting motor threshold (RMT), the H7 coil stimulates the dorsal mPFC and ACC bilaterally. A participant's RMT was determined before the first treatment and at the beginning of each week by ascertaining the coil position that elicited the minimal involuntary contractions of the feet (three of six attempts). The 10Hz group received 10 Hz dTMS at 100% of RMT, with 3-second pulse and 17-second intervals, for a total of 50 trains and 1500 pulses per session. The sham group received treatment with identical technical parameters, which induced scalp sensations but without penetration of the electric field into the brain.

Post-intervention evaluation and one month follow up evaluation are the same as in pre-intervention evaluation.

To ensure study quality, some measures are taken as bellow:

Researchers and drug rehabilitation staff will work together in whole process and the data will be converted into electronic versions once finishing each evaluation.

In the intervention, patients, operators, and raters were blind to treatment condition. Each patient is assigned a magnetic card that determined the coil (real or sham) in the helmet and raters are not present while treatments are administered.

After each treatment times, any side effect from participant's report are recorded to assure the safety and feasibility.

Statistical analyses are performed using SPSS 21.0. The principal statistical analysis is performed using repeated-measures analysis of variance and regression analysis. All missing data will be recorded and marked.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Methamphetamine dependents
  • middle school degree or above

Exclusion criteria

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

Treatment and study plan

real coil

Device

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

Sham coil

Device

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

Primary outcomes

  1. Changes of Cue-induced craving and ERP

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

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

Secondary outcomes

  1. Changes of cognition: behavioral inhibition

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

    using cognitive tasks: stop-signal task

  2. Changes of cognition: working memory

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

    using cognitive tasks: n-back task

  3. Changes of depression status

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

    depression (Beck Depression inventory scale), high score means worse depression

  4. Changes of anxiety status

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

    Anxiety (Beck anxiety inventory scale), higher score means worse anxiety

  5. Changes of sleep status

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

    sleep status measurements (Pittsburgh Sleep Quality Index scale), higher score means worse sleep

  6. Changes of impulsivity

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

    Impulsivity scale (The Barratt Impulsiveness Scale), higher score means higher impulsivity

  7. Changes of resting EEG network

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

    resting EEG signal (Alpha, Beta, Theta, etc) measurement with 128 Channel EGI system

Other outcomes

  1. side effect measurements

    Time frame: every day after each intervention time for the 3 weeks intervention time period

    Side effect scale, including headache, pricking, sleeplessness etc.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 18, 2019
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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