Optimization of NIBS for Treatment of Addiction

Part of paid clinical trials in Hinsdale, Illinois.

Sponsor
Case Western Reserve University
Study ID
NCT04379115
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Pain
  • Opioid-use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Active Comparator: Active tDCS + Active TUS — DEVICE
    Device: Active comparator device: Active transcranial Direct Current Stimulation (tDCS). Subjects will receive 20 minutes of active tDCS. During each Active stimulation session, stimulation will be applied for the full 20 minutes. Device: Active comparator device: Active Transcranial Ultrasound (TUS). Subjects will receive 20 minutes of active Transcranial Ultrasound (TUS). During active stimulation the (TUS) will be active for the full 20 minutes.
  • Sham Comparator: Sham tDCS + Sham TUS — DEVICE
    Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of sham tDCS. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of sham TUS. During sham stimulation the ultrasound will not be active for the full 20 minutes.

Study Details

The purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators hypothesize that there will be a decrease in drug use and improved psychosocial assessments with active stimulation, when compared to sham stimulation.

Key Dates

Start date
Apr 4, 2021
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active (tDCS) + Active TUS
    Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS)
  • Sham Comparator: Sham (tDCS) + Sham TUS
    Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Primary Outcome Measure

Change in drug use from baseline. [ Time Frame: Measured for approximately 6 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Illinois Health/ University of Illinois at ChicagoHinsdaleIllinois60612
Ming-Chieh Shun, PhD
[email protected]
Ciro Ramos Estebanez, MD, PhD
[email protected]
Ciro Ramos Estebanez, MD, PhD (PRINCIPAL_INVESTIGATOR)
Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation CenterCambridgeMassachusetts02138
Elly Pichardo, MD
[email protected]
617-952-6158
Felipe Fregni, MD, PhD
[email protected]
University Hospitals Cleveland Medical Center/ Dahms Clinical Research UnitClevelandOhio44106-1716
Salim Hayek, MD
[email protected]
216-983-2085
Ciro R Estebanez, MD, PhD
[email protected]

Find similar trials in Hinsdale, IL

By research site
University of Illinois Health/ University of Illinois at Chicago· Hinsdale, ILSpaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center· Cambridge, MAUniversity Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit· Cleveland, OH

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