Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
126 participants
INTERVENTIONAL
2021-04-04
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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)
Active Comparator: Active tDCS + Active TUS
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 (tDCS) + Sham TUS
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
Sham Comparator: Sham tDCS + Sham TUS
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.
Interventions
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Active Comparator: Active tDCS + Active TUS
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: 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.
Eligibility Criteria
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Inclusion Criteria
2. 18 to 85 years old.
3. Having a diagnosis of OUD, in the setting of CP:
* OUD of more than 6 months duration as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) \[64\] and a positive urine toxicology screen.
* or OUD patients who still feel craving or have not received more than 60 mg of methadone/day from the Methadone program.
4. Lives in the immediate area with no plans to relocate
Exclusion Criteria
2. Recently started on antiepileptic drug therapy.
3. History of illegal stimulant use as demonstrated by urine toxicology.
4. . Ingestion of poppy seeds or herbal teas containing Papaveris Fructus (may cause a positive opiate test for morphine, codeine \[66, 67\]).
5. History of neurological disorders involving stroke, brain tumors, or epilepsy as self- reported (note patients will also be evaluated via electroencephalography (EEG) at baseline 1 week prior to stimulation and any patient showing abnormal EEG activity will be removed)).
6. History of unexplained fainting spells as self-reported.
7. History of head injury resulting in more than a momentary loss of consciousness as self-reported.
8. History of brain surgery as self-reported.
9. Contraindications to tDCS applied in conjunction with TUS:
* Metal in the head, or
* Implanted brain medical devices.
10. Suffering from severe depression (with a score of \>30 in the Beck Depression Inventory (BDI), PHQ-9≥10).
11. Active malignancy.
12. History of suicidal behavior or suicide attempts.
18 Years
85 Years
ALL
No
Sponsors
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Highland Instruments, Inc.
INDUSTRY
Case Western Reserve University
OTHER
Responsible Party
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Principal Investigators
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Ciro R Estebanez, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center/ Case Western Reserve University
Locations
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University of Illinois Health/ University of Illinois at Chicago
Hinsdale, Illinois, United States
Spaulding Rehabilitation Hospital - 5th Floor - Neuromodulation Center
Cambridge, Massachusetts, United States
University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY20190760
Identifier Type: -
Identifier Source: org_study_id
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