Visceral PainNCT02497196

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

A study testing Active tPCS and Active tDCS in people with Visceral Pain and Pancreatitis, run by Spaulding Rehabilitation Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Visceral Pain, Pancreatitis, Pelvic Pain
What is being tested?: Active tPCS and Active tDCS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 1 siteUnited States
Study dates: Jul 2015to 1 Dec 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 24Show fewer

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:
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

Trial locations and contacts

1 site in 1 country.

United States1 site

Spaulding Rehabilitation Network Research Institute
Charlestown, Massachusetts, 02129

Other trials in United States

About this study

Conditions: Visceral Pain, Pancreatitis, Pelvic Pain
Being tested: Active tPCS, Active tDCS, Sham tPCS, Sham tDCS
Keywords: TPCS, tDCS, visceral pain, pancreatitis, healthy subjects, pelvic pain, neuromodulation, non-invasive brain stimulation
Medical subject headings: Visceral Pain, Pancreatitis, Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active tPCSDevice
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.
Active tDCSDevice
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.
Sham tPCSDevice
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 tDCSDevice
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.

Study groups in NCT02497196
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Device: Sham tPCS; Device: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 20151 Dec 2016

First posted14 Jul 2015 (estimated)
Study startJul 2015
Primary completion1 Oct 2016
Study completion1 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Visceral PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02497196
Sponsor's protocol ID: 2015P000365
Status last verified: Apr 2020
First submitted: 9 Jul 2015
Last updated: 24 Apr 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology
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All Visceral Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurophysiological Effects on tPCS and tDCS on Healthy Subjects and on Patients With Chronic Visceral Pain
ClinicalTrials.gov ID: NCT02497196
Acronym / sponsor ID: 2015P000365
Conditions: Visceral Pain, Pancreatitis, Pelvic Pain
Keywords: TPCS, tDCS, visceral pain, pancreatitis, healthy subjects, pelvic pain, neuromodulation, non-invasive brain stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Spaulding Rehabilitation HospitalUniversity, hospital or other
Study start: Jul 2015
Primary completion: 1 Oct 2016 (actual)
Study completion: 1 Dec 2016 (actual)
First posted: 14 Jul 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Part 1:Active tPCS, Active tDCS	Experimental	Device: Active tPCS, Device: Active tDCS12 out of the 48 total health subjects will receive active tPCS and active tDCS. This will be done for 20 minutes simultaneously.
Part 1: Active tPCS, Sham tDCS	Experimental	Device: Active tPCS, Device: Sham tDCS12 out of the 48 total health subjects will receive active tPCS and sham tDCS. This will be done for 20 minutes simultaneously.
Part 1:Sham tPCS, Active tDCS	Experimental	Device: Active tDCS, Device: Sham tPCS12 out of the 48 total health subjects will receive sham tPCS and active tDCS. This will be done for 20 minutes simultaneously.
Part 1: Sham tDCS, Sham tDCS	Sham comparator	Device: Sham tPCS, Device: Sham tDCS12 out of the 48 total health subjects will receive sham tPCS and sham tDCS. This will be done for 20 minutes simultaneously.
Part 2: Active tPCS/Active tDCS	Experimental	Device: Active tPCS, Device: Active tDCSPart 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: Active tPCS/Sham tDCS	Experimental	Device: Active tPCS, Device: Sham tDCSPart 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: Sham tPCS/Active tDCS	Experimental	Device: Active tDCS, Device: Sham tPCSPart 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).
2: Sham tPCS/Sham tDCS	Sham comparator	Device: Sham tPCS, Device: Sham tDCSPart 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).

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (24 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active tPCSA 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	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 tDCSA 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	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 tPCSSham 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.	Device	2: Sham tPCS/Sham tDCS, Part 1: Sham tDCS, Sham tDCS, Part 1:Sham tPCS, Active tDCS, Part 2: Sham tPCS/Active tDCS
Sham tDCSSham 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	2: Sham tPCS/Sham tDCS, Part 1: Active tPCS, Sham tDCS, Part 1: Sham tDCS, Sham tDCS, Part 2: Active tPCS/Sham tDCS

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

8 secondary outcomes

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
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.
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.
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
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
Depression level as measured Beck Depression Inventory (BDI)
Time frame: 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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.

Related trials for Visceral Pain

RecruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Felipe Fregni, MD, PhD, MPH principal investigator

Spaulding Rehabilitation Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active tPCS and Active tDCS in people with Visceral Pain and Pancreatitis, run by Spaulding Rehabilitation Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02497196.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.