Back to results

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

Primary Purpose

Visceral Pain, Pancreatitis, Pelvic Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active tPCS

Active tDCS

Sham tPCS

Sham tDCS

About this trial

This is an interventional treatment trial for Visceral Pain focused on measuring TPCS, tDCS, visceral pain, pancreatitis, healthy subjects, pelvic pain, neuromodulation, non-invasive brain stimulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Spaulding Rehabilitation Network Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

Part 1:Active tPCS, Active tDCS

Part 1: Active tPCS, Sham tDCS

Part 1:Sham tPCS, Active tDCS

Part 1: Sham tDCS, Sham tDCS

Part 2: Active tPCS/Active tDCS

Part 2: Active tPCS/Sham tDCS

Part 2: Sham tPCS/Active tDCS

2: Sham tPCS/Sham tDCS

Arm Description

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

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

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

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

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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:

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

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)

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)

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

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

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.

Full Information

NCT ID

NCT02497196

First Posted

July 9, 2015

Last Updated

April 23, 2020

Sponsor

Spaulding Rehabilitation Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02497196

Brief Title

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

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

October 1, 2016 (Actual)

Study Completion Date

December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Visceral Pain, Pancreatitis, Pelvic Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1:Active tPCS, Active tDCS

Arm Type

Experimental

Arm Description

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

Arm Title

Part 1: Active tPCS, Sham tDCS

Arm Type

Experimental

Arm Description

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

Arm Title

Part 1:Sham tPCS, Active tDCS

Arm Type

Experimental

Arm Description

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

Arm Title

Part 1: Sham tDCS, Sham tDCS

Arm Type

Sham Comparator

Arm Description

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

Arm Title

Part 2: Active tPCS/Active tDCS

Arm Type

Experimental

Arm Description

Arm Title

Part 2: Active tPCS/Sham tDCS

Arm Type

Experimental

Arm Description

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).

Arm Title

Part 2: Sham tPCS/Active tDCS

Arm Type

Experimental

Arm Description

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).

Arm Title

2: Sham tPCS/Sham tDCS

Arm Type

Sham Comparator

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

Active tPCS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Active tDCS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham tPCS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham tDCS

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

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

Secondary Outcome Measure Information:

Title

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

Description

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

Title

Sensitivity of Filaments as measured by Von Frey assessment

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Pain levels and medication intake as measured Pain/Medication Diary

Description

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.

Time Frame

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

Title

Mood scores as measured Visual Analog Mood Scale (VAMS)

Description

This is a self-reporting assessment in which subjects rate their own emotions, including anxiety, depression, stress, and sleepiness along a 100mm line.

Time Frame

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

Title

Depression level as measured Beck Depression Inventory (BDI)

Description

Time Frame

Done for both healthy and visceral pain subjects during screening (first study visit)

Title

Effectiveness of blinding as measured by the tPCS and tDCS Blinding Questionnaire

Description

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

Title

Side-effects from stimulation as measured by the tDCS and tPCS Side Effects Questionnaire

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felipe Fregni, MD, PhD, MPH

Organizational Affiliation

Spaulding Rehabilitation Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Spaulding Rehabilitation Network Research Institute

City

Charlestown

State/Province

Massachusetts

ZIP/Postal Code

02129

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs