Effects of rTMS and tDCS Treatment on Brain Function, Craving and Relapse Prevention
Effects of Noninvasive Brain Stimulation Methods (rTMS and tDCS) Treatment on Brain Function, Craving and Relapse Prevention
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
Addiction is known as a chronic relapsing brain disorder that has a high cost to patients, family and society. Its ranking in cause of death is 8th globally, and substance abuse contributes 5.4% of the total global burden of disease. Brain stimulation procedures such as repetitive trans-cranial magnetic stimulation (rTMS) and trans-cranial direct current stimulation (tDCS) are considered minimal risk interventions and are used for the treatment of depression, pain, and other neurological and psychiatric disorders. There is some evidence that rTMS applied to the left prefrontal cortex results in significantly lowered craving. To date, no studies have investigated the effects of a course of either rTMS or tDCS treatment on opioid craving, brain function, and relapse prevention in opioid addicts. Individuals with prescription opioid dependence experience high rates of desire and intense cravings to use opioids. The present study aims to examine the effects of a course of daily prefrontal rTMS and tDCS on brain function, desire and craving and help to relapse prevention in abstinence phase.
Trial Health
Trial Health Score
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Started Jun 2015
Shorter than P25 for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 7, 2018
CompletedJune 7, 2018
June 1, 2018
9 months
May 4, 2015
June 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in craving and opioid relapse Using Opioid Cue panel
Using Opioid Cue panel
Day 1, 6 month
Study Arms (4)
20 min active tDCS, and 20 min active rTMS
ACTIVE COMPARATORApplying active tDCS AND active TMS will reduce cue induced craving and opioid use, more than sham TMS AND sham tDCS and also either active TMS OR active tDCS alone. We will apply 10 daily sessions of brain stimulation (1 hour total treatment time). This is composed of 20 minutes active tDCS (anode on F3 EEG positioning and cathode on contra shoulder), followed by 4000 pulses of real rTMS (10Hz over left Dorsolateral Prefrontal Cortex(DLPFC) for 20 minutes at 120%MT). There will be 10 minutes rest between each module. We will test for cue-induced craving scores using VAS and urine drug screens for opioid abuse in comparison to the control group of sham TMS AND sham tDCS and the groups with only active tDCS OR active TMS.
20 min sham tDCS, and 20 min active rTMS
ACTIVE COMPARATORApplying sham tDCS AND active TMS will reduce cue induced craving and opioid use, more than will sham TMS AND sham tDCS. We will apply 10 daily sessions of brain stimulation (1 hour total treatment time). This is composed of with 20 minutes sham tDCS (anode on F3 EEG positioning and cathode on contra shoulder), and 4000 pulses of real rTMS with (10Hz over left DLPFC for 20 minutes at 120%MT. There will be 10 minutes rest between each module. We will test for cue-induced craving scores using VAS and urine drug screens for opioid abuse in comparison to the control group of sham TMS AND sham tDCS.
20 min active tDCS, and 20 min sham rTMS
ACTIVE COMPARATORApplying active tDCS AND sham TMS will reduce cue induced craving and opioid use, more than will sham TMS AND sham tDCS. We will apply 10 daily sessions of brain stimulation (1 hour total treatment time). This is composed of with 20 minutes active tDCS (anode on F3 EEG positioning and cathode on contra shoulder), and 4000 pulses of sham rTMS with (10Hz over left DLPFC for 20 minutes at 120%MT. There will be 10 minutes rest between each module. We will test for cue-induced craving scores using VAS and urine drug screens for opioid abuse in comparison to the control group of sham TMS AND sham tDCS.
20 min sham tDCS, and 20 min sham rTMS
SHAM COMPARATORApplying sham tDCS AND sham TMS will not reduce cue induced craving and opioid use. We will apply 10 sessions of one hour of brain stimulation. We will apply 10 daily sessions of brain stimulation (1 hour total treatment time). This is composed of with 20 minutes sham tDCS (anode on F3 EEG positioning and cathode on contra shoulder), and 4000 pulses of sham rTMS with (10Hz over left DLPFC for 20 minutes at 120%MT. There will be 10 minutes rest between each module. We will test for cue-induced craving scores using VAS and urine drug screens for opioid abuse in comparison to the control group of sham TMS AND sham tDCS.
Interventions
Transcranial magnetic stimulation (TMS) is a minimally invasive brain stimulation method that stimulates the brain of an individual focally(George \& Belmaker, 2007). TMS pulses that are delivered repetitively and rhythmically are referred to as repetitive TMS (rTMS). Transcranial direct current stimulation (tDCS) is another form of non-invasive brain stimulation that is being investigated as an intervention for neurological and psychiatric disorders. A weak direct electrical current (0-2 mA) flows between two small electrodes via saline soaked sponges placed on the scalp (Nitsche MA et al, 2008).
Eligibility Criteria
You may qualify if:
- treatment-seeking opioid-dependent subjects (between the ages of 21 and 65) with at least 30 days of abstinence under maintenance treatment will be included in this single blind study.
You may not qualify if:
- history of seizures,
- receiving any medications known to lower seizure threshold,
- pregnancy,
- metal implants above the waist,
- brain lesions or tumors,
- a history of negative reactions to TMS, and
- a positive opioid urine screen (except methadone and suboxone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2015
First Posted
June 7, 2018
Study Start
June 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
June 7, 2018
Record last verified: 2018-06