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

NCT02497196 | Completed

• 1 other identifier: 2015P000365
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Visceral Pain; Pancreatitis; Pelvic Pain

Keywords

TPCS; tDCS; visceral pain; pancreatitis; healthy subjects; pelvic pain; neuromodulation; non-invasive brain stimulation

Outcome Measures

Primary Outcomes (1)

• Signal Coherence and EEG power as measured Quantitative Electroencephalographic Analysis (qEEG):

  The EEG test is performed to measure the electrical activity in the brain and to examine the dynamic changes.

  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 (8)

• Pressure Values as measured by Pain Pressure Test (PPT) for Conditioned Pain Modulation (CPM)

  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

• Sensitivity of Filaments as measured by Von Frey assessment

  Only done for visceral pain subjects; it will be measured over the course of about 3 weeks.

• Pain score as measured by Visual Analogue Scale (VAS) for Pain:

  Only done for visceral pain subjects; it will be measured over the course of about 3 weeks.

• Pain levels and medication intake as measured Pain/Medication Diary

  Only done for visceral pain subjects; it will be measured over the course of about 3 weeks

• Mood scores as measured Visual Analog Mood Scale (VAMS)

  Only done for visceral pain subjects; it will be measured over the course of about 3 weeks

Study Arms (8)

Part 1:Active tPCS, Active tDCS

EXPERIMENTAL

12 out of the 48 total health subjects will receive active tPCS and active tDCS. This will be done for 20 minutes simultaneously.

Device: Active tPCS; Device: Active tDCS

Part 1: Active tPCS, Sham tDCS

EXPERIMENTAL

12 out of the 48 total health subjects will receive active tPCS and sham tDCS. This will be done for 20 minutes simultaneously.

Device: Active tPCS; Device: Sham tDCS

Part 1:Sham tPCS, Active tDCS

EXPERIMENTAL

12 out of the 48 total health subjects will receive sham tPCS and active tDCS. This will be done for 20 minutes simultaneously.

Device: Active tDCS; Device: Sham tPCS

Part 1: Sham tDCS, Sham tDCS

SHAM COMPARATOR

12 out of the 48 total health subjects will receive sham tPCS and sham tDCS. This will be done for 20 minutes simultaneously.

Device: Sham tPCS; Device: Sham tDCS

Part 2: Active tPCS/Active tDCS

EXPERIMENTAL

Part 2 will run as a four-period crossover design, where all chronic visceral pain subjects (18 total) will be receiving all (4) possible combinations of tDCS and tPCS interventions (active or sham) at the end of the experiment in a random, consecutive way. This represents the combination of receiving active tPCS and active tDCS (1/4 combinations all subjects will receive).

Device: Active tPCS; Device: Active tDCS

Part 2: Active tPCS/Sham tDCS

EXPERIMENTAL

Part 2 will run as a four-period crossover design, where all chronic visceral pain subjects (18 total) will be receiving all (4) possible combinations of tDCS and tPCS interventions (active or sham) at the end of the experiment in a random, consecutive way. This represents the combination of receiving active tPCS and sham tDCS (1/4 combinations all subjects will receive).

Device: Active tPCS; Device: Sham tDCS

Part 2: Sham tPCS/Active tDCS

EXPERIMENTAL

Part 2 will run as a four-period crossover design, where all chronic visceral pain subjects (18 total) will be receiving all (4) possible combinations of tDCS and tPCS interventions (active or sham) at the end of the experiment in a random, consecutive way. This represents the combination of receiving sham tPCS and active tDCS (1/4 combinations all subjects will receive).

Device: Active tDCS; Device: Sham tPCS

2: Sham tPCS/Sham tDCS

SHAM COMPARATOR

Part 2 will run as a four-period crossover design, where all chronic visceral pain subjects (18 total) will be receiving all (4) possible combinations of tDCS and tPCS interventions (active or sham) at the end of the experiment in a random, consecutive way. This represents the combination of receiving sham tPCS and sham tDCS (1/4 combinations all subjects will receive).

Device: Sham tPCS; Device: Sham tDCS

Interventions

Active tPCS DEVICE

A current intensity of 2mA and a stimulation frequency range of 6-10 Hz will be used with a peri-aurical ear-clip electrode montage for 20 minutes.

Part 1: Active tPCS, Sham tDCS; Part 1:Active tPCS, Active tDCS; Part 2: Active tPCS/Active tDCS; Part 2: Active tPCS/Sham tDCS

Active tDCS DEVICE

A current intensity of 2.0 mA will be used for 20 minutes. The electrodes that will be used will be standard sponge electrodes. The anode will be placed over left motor cortex. The cathode electrode will be placed over the contralateral supraorbitofrontal area.

Part 1:Active tPCS, Active tDCS; Part 1:Sham tPCS, Active tDCS; Part 2: Active tPCS/Active tDCS; Part 2: Sham tPCS/Active tDCS

Sham tPCS DEVICE

Sham tPCS stimulation will consist of applying the same parameters as for active, but the corresponding device will be turned off after 30 seconds, as to simulate the initial sensation of the active current. A current intensity of 2mA and a stimulation frequency range of 6-10 Hz will still be used (only this will be turned off after 30 seconds using ramping) with a peri-aurical ear-clip electrode montage.

2: Sham tPCS/Sham tDCS; Part 1: Sham tDCS, Sham tDCS; Part 1:Sham tPCS, Active tDCS; Part 2: Sham tPCS/Active tDCS

Sham tDCS DEVICE

Sham tDCS stimulation will consist of applying the same parameters as for active, but the corresponding device will be turned off after 30 seconds, as to simulate the initial sensation of the active current. A current intensity of 2.0 mA will still be used (but turned off after 30 seconds using ramping). The electrodes that will be used will be same, standard sponge electrodes. The anode will be placed over the left motor cortex The cathode electrode will be placed over the contralateral supraorbitofrontal area.

2: Sham tPCS/Sham tDCS; Part 1: Active tPCS, Sham tDCS; Part 1: Sham tDCS, Sham tDCS; Part 2: Active tPCS/Sham tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Provide informed consent to participate in the study
• Age 18 - 60 years
• 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:

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Visceral Pain; Pancreatitis; Pelvic Pain

Condition Hierarchy (Ancestors)

Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Felipe Fregni, MD, PhD, MPH

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 14, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (1)