Predicting Pain Response to Transcranial Direct Current S... | NCT02627495

NCT02627495

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
tDCS intervention (open label)	Experimental	Subjects will undergo tDCS stimulation	Device: transcranial Direct Current Stimulation (tDCS): (Soterix ©)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transcranial Direct Current Stimulation (tDCS): (Soterix ©)	Device	Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain as Measured by the Visual Analog Scale	The VAS is a common assessment used which asks subjects to self-reportedly measure their pain on a visual scale (i.e., unbearable to none). We will use a VAS to determine subjects' pain scores. Subjects will rate their pain from 0 - indicating no pain at all, to 10 - indicating the worst pain felt. This scale is also colored, from green (at 0) to red (at 10), as a visual indicator of pain.	Change in outcome from baseline to 2-week follow-up (after the last day of stimulation)

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Spaulding Rehabilitation Hospital		Boston	Massachusetts	02129	United States

Arm/Group Information

ID	Title	Description
FG000	tDCS Intervention (Open Label)	Subjects will undergo tDCS stimulation transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	tDCS Intervention (Open Label)	Subjects will undergo tDCS stimulation transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Pain as Measured by the Visual Analog Scale

The VAS is a common assessment used which asks subjects to self-reportedly measure their pain on a visual scale (i.e., unbearable to none). We will use a VAS to determine subjects' pain scores. Subjects will rate their pain from 0 - indicating no pain at all, to 10 - indicating the worst pain felt. This scale is also colored, from green (at 0) to red (at 10), as a visual indicator of pain.

Posted

Mean

Standard Deviation

units on a scale

Change in outcome from baseline to 2-week follow-up (after the last day of stimulation)

ID	Title	Description
OG000	tDCS Intervention (Open Label)	Subjects will undergo tDCS stimulation transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	tDCS Intervention (Open Label)	Subjects will undergo tDCS stimulation transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies