Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04202926
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2019-11-30
Brief Title:
Repetitive dTMS Intervention for Methamphetamine Addiction
Sponsor:
Shanghai Mental Health Center
Organization:
Shanghai Mental Health Center
Study Overview
Official Title:
Repetitive dTMS Intervention for Methamphetamine Addiction
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 UK 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 participants 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 participants report are recorded to assure the safety and feasibility
Statistical analyses are performed using SPSS 210 The principal statistical analysis is performed using repeated-measures analysis of variance and regression analysis All missing data will be recorded and marked
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 UK 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 participants 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 participants report are recorded to assure the safety and feasibility
Statistical analyses are performed using SPSS 210 The principal statistical analysis is performed using repeated-measures analysis of variance and regression analysis All missing data will be recorded and marked
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None