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

April 23, 2020 updated by: Felipe Fregni, Spaulding Rehabilitation Hospital
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Spaulding Rehabilitation Network Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1:Active tPCS, Active tDCS
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
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.
Device: Active tDCS
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.
Experimental: Part 1: Active tPCS, Sham tDCS
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
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.
Device: Sham tDCS
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.
Experimental: Part 1:Sham tPCS, Active tDCS
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
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.
Device: Sham tPCS
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.
Sham Comparator: Part 1: Sham tDCS, Sham tDCS
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 tDCS
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.
Device: Sham tPCS
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.
Experimental: Part 2: Active tPCS/Active tDCS
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
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.
Device: Active tDCS
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.
Experimental: Part 2: Active tPCS/Sham tDCS
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
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.
Device: Sham tDCS
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.
Experimental: Part 2: Sham tPCS/Active tDCS
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
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.
Device: Sham tPCS
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.
Sham Comparator: 2: Sham tPCS/Sham tDCS
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 tDCS
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.
Device: Sham tPCS
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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:
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.
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
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.
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)
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.
Only done for visceral pain subjects; it will be measured over the course of about 3 weeks
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.
Done for both healthy and visceral pain subjects during screening (first study visit)
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.
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spaulding Rehabilitation Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015P000365

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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