Clinical Trial: Neurophysiological Effects on tPCS and tDCS on Healthy Subjects and on Patients With Chronic Visceral Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Neurophysiological Effects on tPCS and tDCS on Healthy Subjects and on Patients With Chronic Visceral Pain

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.

Detailed Summary:
Sponsor: Spaulding Rehabilitation Hospital

Current Primary Outcome: Signal Coherence and EEG power as measured Quantitative Electroencephalographic Analysis (qEEG): [ Time Frame: 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 ]

Original Primary Outcome: Quantitative Electroencephalographic Analysis (qEEG): [ Time Frame: 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 ]

Current Secondary Outcome:

• Pressure Values as measured by Pain Pressure Test (PPT) for Conditioned Pain Modulation (CPM) [ Time Frame: 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 ]
  These procedures incorporate a conditioning stimulus (a noxious stimulus that evokes Descending Noxious Inhibitory Control (DNIC) activation) and a test stimulus (a noxious stimulus used to evaluate the analgesic response to the conditioning stimulus- this will be the PPT as determined by an algometer (JTECH medical)). This study will evaluate CPM in healthy subjects as well as in patients with chronic visceral pain using pressure as the test stimulus, and cold water as the conditioning stimulus.
• Sensitivity of Filaments as measured by Von Frey assessment [ Time Frame: Only done for visceral pain subjects; it will be measured over the course of about 3 weeks. ]
  This assessment will be performed before and after every intervention on a patient with pain. Mechanical perception and pain threshold will be tested on the painful region and on other non-painful area Von Frey monofilaments (0.4 g to 50 g) (these are fine filaments that can test a subject's perception threshold when they are applied to the body surface). Monofilament application will be applied to the painful region and a non painful region on the same side of the body (i. e. left or right). The hairs will be applied until subject perceives the stimulus (perception threshold) and describes it as painful (pain threshold). The threshold will be taken as the lowest force that causes pain perception in the affected and contralateral mirror healthy site.
• Pain score as measured by Visual Analogue Scale (VAS) for Pain: [ Time Frame: Only done for visceral pain subjects; it will be measured over the course of about 3 weeks. ]
  The VAS is a self-reporting test asking subjects to self-measure their pain on a visual scale from zero to ten (i.e., none to unbearable). This will help us monitor changes in subjects' pain levels when they come in for sessions.
• Pain levels and medication intake as measured Pain/Medication Diary [ Time Frame: Only done for visceral pain subjects; it will be measured over the course of about 3 weeks ]
  To monitor pain levels, as well as safety, patients with chronic visceral pain will keep a diary listing their daily medications and pain levels when not at the laboratory.
• Mood scores as measured Visual Analog Mood Scale (VAMS) [ Time Frame: Only done for visceral pain subjects; it will be measured over the course of about 3 weeks ]
  This is a self-reporting assessment in which subjects rate their own emotions, including anxiety, depression, stress, and sleepiness along a 100mm line.
• Depression level as measured Beck Depression Inventory (BDI) [ Time Frame: Done for both healthy and visceral pain subjects during screening (first study visit) ]
  A 21-item, multiple-choice questionnaire will be administered at the beginning of the study to all subjects to assess the presence and degree of depression in adults, as studies in chronic pain have found that depression can modulate pain perception.
• Effectiveness of blinding as measured by the tPCS and tDCS Blinding Questionnaire [ Time Frame: 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 ]
  After the stimulation session, subjects will complete a questionnaire to determine if the blinding methods were effective. A 30s sham montage is used,which is consistent with other trials, keeping the device on the subject for the duration of the session.
• Side-effects from stimulation as measured by the tDCS and tPCS Side Effects Questionnaire [ Time Frame: 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 ]
  At the end of each stimulation session, subjects will complete a questionnaire to evaluate potential side effects of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale. Subjects will be asked whether they have experienced any side effects in open-ended questions. They will also be specifically asked about headache, neck pain, scalp pain, scalp burns, tingling, skin redness, sleepiness, trouble concentrating, and acute mood change. If any side effects are reported, the degree of relatedness to the intervention will be assessed.This assessment identifies adverse effects using open-ended questions.

Original Secondary Outcome:

• Pain Pressure Test (PPT) for Conditioned Pain Modulation (CPM) [ Time Frame: 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 ]
  These procedures incorporate a conditioning stimulus (a noxious stimulus that evokes Descending Noxious Inhibitory Control (DNIC) activation) and a test stimulus (a noxious stimulus used to evaluate the analgesic response to the conditioning stimulus- this will be the PPT as determined by an algometer (JTECH medical)). This study will evaluate CPM in healthy subjects as well as in patients with chronic visceral pain using pressure as the test stimulus, and cold water as the conditioning stimulus.
• Von Frey assessment [ Time Frame: Only done for visceral pain subjects; it will be measured over the course of about 3 weeks. ]
  This assessment will be performed before and after every intervention on a patient with pain. Mechanical perception and pain threshold will be tested on the painful region and on other non-painful area Von Frey monofilaments (0.4 g to 50 g) (these are fine filaments that can test a subject's perception threshold when they are applied to the body surface). Monofilament application will be applied to the painful region and a non painful region on the same side of the body (i. e. left or right). The hairs will be applied until subject perceives the stimulus (perception threshold) and describes it as painful (pain threshold). The threshold will be taken as the lowest force that causes pain perception in the affected and contralateral mirror healthy site.
• Visual Analogue Scale (VAS) for Pain: [ Time Frame: Only done for visceral pain subjects; it will be measured over the course of about 3 weeks. ]
  The VAS is a self-reporting test asking subjects to self-measure their pain on a visual scale from zero to ten (i.e., none to unbearable). This will help us monitor changes in subjects' pain levels when they come in for sessions.
• Pain/Medication Diary [ Time Frame: Only done for visceral pain subjects; it will be measured over the course of about 3 weeks ]
  To monitor pain levels, as well as safety, patients with chronic visceral pain will keep a diary listing their daily medications and pain levels when not at the laboratory.
• Visual Analog Mood Scale (VAMS) [ Time Frame: Only done for visceral pain subjects; it will be measured over the course of about 3 weeks ]
  This is a self-reporting assessment in which subjects rate their own emotions, including anxiety, depression, stress, and sleepiness along a 100mm line.
• Beck Depression Inventory (BDI) [ Time Frame: Done for both healthy and visceral pain subjects during screening (first study visit) ]
  A 21-item, multiple-choice questionnaire will be administered at the beginning of the study to all subjects to assess the presence and degree of depression in adults, as studies in chronic pain have found that depression can modulate pain perception.
• tPCS and tDCS Blinding Questionnaire [ Time Frame: 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 ]
  After the stimulation session, subjects will complete a questionnaire to determine if our blinding methods were effective. We are using a 30s sham montage, just as we use in our other trials, keeping the device on the subject for the duration of the session.
• tDCS and tPCS Side Effects Questionnaire [ Time Frame: 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 ]
  At the end of each stimulation session, subjects will complete a questionnaire to evaluate potential side effects of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale. Subjects will be asked whether they have experienced any side effects in open-ended questions. They will also be specifically asked about headache, neck pain, scalp pain, scalp burns, tingling, skin redness, sleepiness, trouble concentrating, and acute mood change. If any side effects are reported, the degree of relatedness to the intervention will be assessed. We will assess adverse effects using open-ended questions.

Dates:
Date Received: July 9, 2015
Date Started: July 2015
Date Completion:
Last Updated: March 17, 2017
Last Verified: March 2017