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

NCT ID: NCT02497196

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active tPCS

Intervention Type: 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.

Active tDCS

Intervention Type: 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, 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.

Group Type: EXPERIMENTAL

Active tPCS

Intervention Type: 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.

Sham tDCS

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Active tDCS

Intervention Type: 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.

Sham tPCS

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Sham tPCS

Intervention Type: 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.

Sham tDCS

Intervention Type: 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.

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).

Group Type: EXPERIMENTAL

Active tPCS

Intervention Type: 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.

Active tDCS

Intervention Type: 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 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).

Group Type: EXPERIMENTAL

Active tPCS

Intervention Type: 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.

Sham tDCS

Intervention Type: 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.

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).

Group Type: EXPERIMENTAL

Active tDCS

Intervention Type: 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.

Sham tPCS

Intervention Type: 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 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).

Group Type: SHAM_COMPARATOR

Sham tPCS

Intervention Type: 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.

Sham tDCS

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

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:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Felipe Fregni

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe Fregni, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, United States

Countries

United States

Other Identifiers

2015P000365

Identifier Type: -

Identifier Source: org_study_id