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

Mass General Brigham

Status: Completed

Conditions: Pelvic Pain; Pancreatitis; Visceral Pain

Treatments: Device: Active tPCS; Device: Active tDCS; Device: Sham tPCS; Device: Sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02497196

2015P000365

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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54 participants in 8 patient groups

Part 1:Active tPCS, Active tDCS

Experimental group

Description:

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

Treatment:

Device: Active tDCS

Device: Active tPCS

Part 1: Active tPCS, Sham tDCS

Experimental group

Description:

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

Treatment:

Device: Sham tDCS

Device: Active tPCS

Part 1:Sham tPCS, Active tDCS

Experimental group

Description:

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

Treatment:

Device: Active tDCS

Device: Sham tPCS

Part 1: Sham tDCS, Sham tDCS

Sham Comparator group

Description:

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

Treatment:

Device: Sham tDCS

Device: Sham tPCS

Part 2: Active tPCS/Active tDCS

Experimental group

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 active tDCS (1/4 combinations all subjects will receive).

Treatment:

Device: Active tDCS

Device: Active tPCS

Part 2: Active tPCS/Sham tDCS

Experimental group

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).

Treatment:

Device: Sham tDCS

Device: Active tPCS

Part 2: Sham tPCS/Active tDCS

Experimental group

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).

Treatment:

Device: Active tDCS

Device: Sham tPCS

2: Sham tPCS/Sham tDCS

Sham Comparator group

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).

Treatment:

Device: Sham tDCS

Device: Sham tPCS