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

Primary Purpose

Addiction

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brain Stimulation
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Addiction focused on measuring Brain stimulation

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Sham Comparator

    Arm Label

    20 min active tDCS, and 20 min active rTMS

    20 min sham tDCS, and 20 min active rTMS

    20 min active tDCS, and 20 min sham rTMS

    20 min sham tDCS, and 20 min sham rTMS

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in craving and opioid relapse Using Opioid Cue panel
    Using Opioid Cue panel

    Secondary Outcome Measures

    Full Information

    First Posted
    May 4, 2015
    Last Updated
    June 5, 2018
    Sponsor
    Medical University of South Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03549065
    Brief Title
    Effects of rTMS and tDCS Treatment on Brain Function, Craving and Relapse Prevention
    Official Title
    Effects of Noninvasive Brain Stimulation Methods (rTMS and tDCS) Treatment on Brain Function, Craving and Relapse Prevention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of South Carolina

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Addiction
    Keywords
    Brain stimulation

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    20 min active tDCS, and 20 min active rTMS
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    20 min sham tDCS, and 20 min active rTMS
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    20 min active tDCS, and 20 min sham rTMS
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    20 min sham tDCS, and 20 min sham rTMS
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Brain Stimulation
    Intervention Description
    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 Measure Information:
    Title
    Change in craving and opioid relapse Using Opioid Cue panel
    Description
    Using Opioid Cue panel
    Time Frame
    Day 1, 6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

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

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