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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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2024-08-31
2026-08-31
Brief Summary
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Study outcomes will include changes in pain levels and vital signs. For patients who are admitted after surgery, opioid consumption in the 24 hours after surgery and time from surgery to discharge are recorded as secondary outcomes.
Patients will be divided in the following comparison groups:
* Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.
* Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.
* Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.
* Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.
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Detailed Description
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This study seeks to evaluate the efficacy of tDCS and VNS in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery by randomizing 200 subjects in 4 groups:
* Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.
* Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.
* Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.
* Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.
Patient's vital signs and pain level will be obtained before the procedure and after. Patients that have to stay in hospital will also be evaluated by opioid consumption and time from surgery to discharge.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group +/+
Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.
Active transcranial direct current stimulation
Ten minutes of active transcranial direct current stimulation
Active vagus nerve stimulation
Ten minutes of active vagus nerve stimulation
Group +/-
Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.
Active transcranial direct current stimulation
Ten minutes of active transcranial direct current stimulation
Sham vagus nerve stimulation
Ten minutes of sham VNS
Group -/+
Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.
Active vagus nerve stimulation
Ten minutes of active vagus nerve stimulation
Sham transcranial direct current stimulation
Ten minutes of sham tDCS
Group -/-
Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.
Sham transcranial direct current stimulation
Ten minutes of sham tDCS
Sham vagus nerve stimulation
Ten minutes of sham VNS
Interventions
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Active transcranial direct current stimulation
Ten minutes of active transcranial direct current stimulation
Active vagus nerve stimulation
Ten minutes of active vagus nerve stimulation
Sham transcranial direct current stimulation
Ten minutes of sham tDCS
Sham vagus nerve stimulation
Ten minutes of sham VNS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients with metal implants around the chest, neck, or head (e.g. implantable pacemakers and defibrillators, deep brain stimulation devices);
* pregnancy
* history of epilepsy or seizures.
* patients undergoing surgical procedures involving the head, neck or spine, or those requiring the use of cardiopulmonary bypass
18 Years
ALL
Yes
Sponsors
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Columbia University
OTHER
Responsible Party
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Paul Garcia
Associate Professor of Anesthesiology, Division Chief of Neuroanesthesia
Central Contacts
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Other Identifiers
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AAAV2033
Identifier Type: -
Identifier Source: org_study_id
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