Neurophysiological Effects on tPCS and tDCS on Healthy Subjects and on Patients With Chronic Visceral Pain
CompletedNot applicableNCT02497196
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study investigates comparing the effects of transcranial Pulsed Current Stimulation and transcranial Direct Current Stimulation (tDCS) (Soterix ©) and their combination on neurophysiological outcomes on healthy subjects as well as on the clinical population for chronic visceral pain. The study also aims to evaluate the effects of these techniques on pain thresholds in healthy subjects as well as for chronic visceral pain patients.
Study details
- Official title
- Neurophysiological Effects on tPCS and tDCS on Healthy Subjects and on Patients With Chronic Visceral Pain
- Conditions
- Visceral Pain
- Pancreatitis
- Pelvic Pain
- Interventions
- Device: Active tPCS
- Device: Active tDCS
- Device: Sham tPCS
- Device: Sham tDCS
- Sponsor
- Spaulding Rehabilitation Hospital
- Start date
- 2015-07
- Primary completion
- 2016-10-01
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
PART 1: 48 healthy subjects will be selected to take part in this study. All healthy subjects will need to meet all of the following inclusion criteria and none of the following exclusion criteria: Inclusion criteria: * Provide informed consent to participate in the study * Age 18 - 60 years Exclusion criteria: * History of alcohol or substance abuse within the last 6 months as self-reported * Severe depression (with a score of \>30 in the Beck Depression Inventory)\* * History of seizures during the last two years or diagnosis of epilepsy * History of neurological or psychiatric illness * Unstable medical conditions such as uncontrolled diabetes mellitus, uncompensated cardiac pathology, heart failure, kidney insufficiency or chronic obstructive pulmonary disease, acute thrombosis * History of head injury resulting in more than a momentary loss of consciousness during the last two years * History of unexplained fainting spells or loss of consciousness as self-reported during the last two years * Contraindication to tPCS or tDCS * Metallic brain implants * Implanted brain electronic medical devices * Pregnancy * Use of neuropsychotropic drugs within the past two weeks as self reported Part 2: 18 patients with Chronic Visceral Pain will take part in this experiment. All subjects must meet the following criteria: Inclusion criteria: * Provide informed consent to participate in the study * Age 18 - 60 years * Abdominal or pelvic pain for ≥ 3 days per week for at least 3 months (average VAS scale score of 4/10 or greater at time of enrollment) as self reported * Diagnosis of chronic visceral pain (e.g. Chronic Pancreatitis or Chronic Pelvic Pain) as confirmed by medical records or a letter from their physician * If taking pain medications, stable doses are required for at two weeks prior to initiation of the study Exclusion criteria: * History of alcohol or substance abuse within the last 6 months as self-reported * Severe depression (with a score of \>30 in the Beck Depression Inventory)\* * Epilepsy * Unstable medical conditions such as uncontrolled diabetes mellitus, uncompensated cardiac pathology, heart failure, kidney insufficiency or chronic obstructive pulmonary disease, acute thrombosis * History of head injury resulting in more than a momentary loss of consciousness during the last two years * History of unexplained fainting spells or loss of consciousness as self-reported during the last two years * Contraindication to tPCS or tDCS * Metallic brain …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02497196