Clinical trial NCT02497196: Neurophysiological Effects on tPCS and tDCS on Healthy Subjects and on Patients With Chronic Visceral Pain
Official title: Neurophysiological Effects on tPCS and tDCS on Healthy Subjects and on Patients With Chronic Visceral Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visceral Pain
Pancreatitis
Pelvic Pain
Keywords: TPCS
tDCS
visceral pain
pancreatitis
healthy subjects
pelvic pain
neuromodulation
non-invasive brain stimulation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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 implants
* Implanted brain electronic medical devices
* Pregnancy or trying to become pregnant during the next month
* Use of carbamazepine oxcarbazepine, phenytoin, pramipexole (Mirapex), or cavergoline (Dostinex) within the past 6 months as self-reported

Primary outcomes:
measure: Signal Coherence and EEG power as measured Quantitative Electroencephalographic Analysis (qEEG):
timeFrame: For the healthy subjects during their 1-time study visit; For visceral pain patients, it will be measured over the course of about 3 weeks
Secondary outcomes:
measure: Pressure Values as measured by Pain Pressure Test (PPT) for Conditioned Pain Modulation (CPM)
timeFrame: For the healthy subjects during their 1-time study visit; For visceral pain subjects, it will be measured over the course of about 3 weeks
measure: Sensitivity of Filaments as measured by Von Frey assessment
timeFrame: Only done for visceral pain subjects; it will be measured over the course of about 3 weeks.
measure: Pain score as measured by Visual Analogue Scale (VAS) for Pain:
timeFrame: Only done for visceral pain subjects; it will be measured over the course of about 3 weeks.
measure: Pain levels and medication intake as measured Pain/Medication Diary
timeFrame: Only done for visceral pain subjects; it will be measured over the course of about 3 weeks
measure: Mood scores as measured Visual Analog Mood Scale (VAMS)
timeFrame: Only done for visceral pain subjects; it will be measured over the course of about 3 weeks
measure: Depression level as measured Beck Depression Inventory (BDI)
timeFrame: Done for both healthy and visceral pain subjects during screening (first study visit)
measure: Effectiveness of blinding as measured by the tPCS and tDCS Blinding Questionnaire
timeFrame: For the healthy subjects during their 1-time study visit; For visceral pain subjects, it will be measured over the course of about 3 weeks
measure: Side-effects from stimulation as measured by the tDCS and tPCS Side Effects Questionnaire
timeFrame: For the healthy subjects during their 1-time study visit; For visceral pain subjects, it will be measured over the course of about 3 weeks
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Network Research Institute
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Felipe Fregni, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: