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Effects of rTMS and tDCS Treatment on Brain Function, Craving and Relapse Prevention

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ClinicalTrials.gov Identifier: NCT03549065
Recruitment Status : Withdrawn
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Addiction Device: Brain Stimulation Not Applicable

Detailed Description:
The investigators plan to compare and contrast TMS and tDCS alone or in combination to treat opioid abuse. We will use a 4 cell randomised parallel controlled trial, consisting of active or sham TMS, and active or sham tDCS [a-tDCS, a-TMS; s-tDCS, a-TMS; a-tDCS, s-TMS; s-tDCS, s-TMS). The investigators hypothesise that each of the active interventions alone will be superior to pure sham in reducing craving and use. Moreover, The investigators hypothesise that COMBINING the two active treatments will be synergistic and will produce the largest reductions in craving and use.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effects of Noninvasive Brain Stimulation Methods (rTMS and tDCS) Treatment on Brain Function, Craving and Relapse Prevention
Study Start Date : June 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Active Comparator: 20 min active tDCS, and 20 min active rTMS
Applying 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.
Device: Brain Stimulation

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).


Active Comparator: 20 min sham tDCS, and 20 min active rTMS
Applying 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.
Device: Brain Stimulation

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).


Active Comparator: 20 min active tDCS, and 20 min sham rTMS
Applying 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.
Device: Brain Stimulation

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).


Sham Comparator: 20 min sham tDCS, and 20 min sham rTMS
Applying 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.
Device: Brain Stimulation

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).





Primary Outcome Measures :
  1. Change in craving and opioid relapse Using Opioid Cue panel [ Time Frame: Day 1, 6 month ]
    Using Opioid Cue panel



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40 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.

Exclusion criteria includes:

  • 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

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03549065     History of Changes
Other Study ID Numbers: MUSouthCarolina
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018

Keywords provided by Medical University of South Carolina:
Brain stimulation