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Transcranial Stimulation (tDCS) For the Treatment of Neuropathic Facial Pain (TDCS)

Primary Purpose

Facial Pain

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sponsored by
Beth Israel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial Pain focused on measuring tDCS, Neuropathic, Facial, Pain, Neuralgia, deafferentation, Trigeminal

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Spontaneous facial neuropathic pain due to any of following:

    1. Trigeminal neuralgia, type 1, (TN1): facial pain of spontaneous onset with predominantly episodic pain.
    2. Trigeminal neuralgia, type 2, (TN2): facial pain of spontaneous onset with predominantly constant pain.
    3. Trigeminal neuropathic pain, (TNP): facial pain resulting from unintentional injury to the trigeminal system from facial trauma, oral surgery, ear, nose and throat (ENT) surgery, root injury from posterior fossa or skull base surgery, stroke, etc.
    4. Trigeminal deafferentation pain, (TDP): facial pain in a region of trigeminal numbness resulting from intentional injury to the trigeminal system from neurectomy, gangliolysis, rhizotomy, nucleotomy, tractotomy, or other denervating procedures.
    5. Symptomatic trigeminal neuralgia, (STN): facial pain resulting from multiple sclerosis.

    e) Postherpetic neuralgia, (PHN): facial pain resulting from trigeminal Herpes zoster (shingles) outbreak in the trigeminal distribution.

  • Pain intensity score for "worst pain in the last 24 hours" >4 on a numeric scale 0-10 at the time of enrollment and before the first stimulation of each treatment block.
  • Pain intensity score for "pain right now" >4 on a numeric scale 0-10 before the first stimulation of each block of treatment.

Exclusion Criteria:

  • Uncontrolled hypertension, uncontrolled diabetes, uncontrolled cardiovascular disease
  • Other painful conditions than neuropathic facial pain, that are not related to and can't be distinguished from the neuropathic facial pain
  • Pregnancy
  • Implanted neurostimulation devices (e.g. a spinal cord stimulator, a deep brain stimulator, etc)
  • Active illegal drug/alcohol abuse
  • Unable to follow directions or complete tools in English.

Sites / Locations

  • Beth Israel Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Group A: Anodal tDCS

Arm B: Cathodal tDCS

Arm Description

Group A will receive one block of real excitatory anodal tDCS over the motor cortex and one block of sham.

Group B will receive one block of inhibitory cathodal tDCS over the somatosensory cortex and one block of sham.

Outcomes

Primary Outcome Measures

Primary outcome will be a composite measure "Pain intensity/consumption of pain medication".
The washout period between phase I and phase II of the study is variable as patients have to go back to their baseline.

Secondary Outcome Measures

Full Information

First Posted
December 27, 2012
Last Updated
December 9, 2015
Sponsor
Beth Israel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01849796
Brief Title
Transcranial Stimulation (tDCS) For the Treatment of Neuropathic Facial Pain
Acronym
TDCS
Official Title
Transcranial Stimulation (TDCS) For The Treatment of Neuropathic Facial Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Investigators moved to other institutions
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A study to determine if transcranial direct current stimulation (tDCS, the device that regulates brain activity, can improve pain in people with neuropathic facial pain and compare which modality (inhibitory tDCS over the somatosensory cortex or excitatory tDCS over the motor cortex) can result in better pain-relief.)
Detailed Description
This is a pilot study designed to collect preliminary data on safety and efficacy of transcranial direct current stimulation (tDCS)to relieve pain in subjects with neuropathic facial pain,and to compare two pain-treatment tDCS modalities: inhibitory tDCS stimulation over the somatosensory cortex and excitatory tDCS over the motor cortex.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Pain
Keywords
tDCS, Neuropathic, Facial, Pain, Neuralgia, deafferentation, Trigeminal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Anodal tDCS
Arm Type
Active Comparator
Arm Description
Group A will receive one block of real excitatory anodal tDCS over the motor cortex and one block of sham.
Arm Title
Arm B: Cathodal tDCS
Arm Type
Sham Comparator
Arm Description
Group B will receive one block of inhibitory cathodal tDCS over the somatosensory cortex and one block of sham.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
TDCS/sham will be delivered using the battery-operated device Phoresor II Auto with two saline-soaked sponge electrodes. To deliver excitatory (anodal) tDCS over the motor cortex, the main electrode will be placed over the motor cortex on the hemisphere contralateral to the major source of pain. The second electrode will be placed on the skin overlying the supraorbital region ipsilateral to the affected area. To deliver inhibitory (cathodal) tDCS, the main electrode will be placed over the somatosensory cortex on the hemisphere contralateral to the major source of pain. The second electrode will be placed on the skin overlying the supraorbital region ipsilateral to the affected area. The current will be delivered at the intensity of 2mA for 20 minutes. To deliver sham, the current will be delivered for 30 sec only to elicit tingling skin sensation but no cortical excitability changes.
Primary Outcome Measure Information:
Title
Primary outcome will be a composite measure "Pain intensity/consumption of pain medication".
Description
The washout period between phase I and phase II of the study is variable as patients have to go back to their baseline.
Time Frame
Daily from Baseline to up to 17 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Spontaneous facial neuropathic pain due to any of following: Trigeminal neuralgia, type 1, (TN1): facial pain of spontaneous onset with predominantly episodic pain. Trigeminal neuralgia, type 2, (TN2): facial pain of spontaneous onset with predominantly constant pain. Trigeminal neuropathic pain, (TNP): facial pain resulting from unintentional injury to the trigeminal system from facial trauma, oral surgery, ear, nose and throat (ENT) surgery, root injury from posterior fossa or skull base surgery, stroke, etc. Trigeminal deafferentation pain, (TDP): facial pain in a region of trigeminal numbness resulting from intentional injury to the trigeminal system from neurectomy, gangliolysis, rhizotomy, nucleotomy, tractotomy, or other denervating procedures. Symptomatic trigeminal neuralgia, (STN): facial pain resulting from multiple sclerosis. e) Postherpetic neuralgia, (PHN): facial pain resulting from trigeminal Herpes zoster (shingles) outbreak in the trigeminal distribution. Pain intensity score for "worst pain in the last 24 hours" >4 on a numeric scale 0-10 at the time of enrollment and before the first stimulation of each treatment block. Pain intensity score for "pain right now" >4 on a numeric scale 0-10 before the first stimulation of each block of treatment. Exclusion Criteria: Uncontrolled hypertension, uncontrolled diabetes, uncontrolled cardiovascular disease Other painful conditions than neuropathic facial pain, that are not related to and can't be distinguished from the neuropathic facial pain Pregnancy Implanted neurostimulation devices (e.g. a spinal cord stimulator, a deep brain stimulator, etc) Active illegal drug/alcohol abuse Unable to follow directions or complete tools in English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy Hao, MD
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States

12. IPD Sharing Statement

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Transcranial Stimulation (tDCS) For the Treatment of Neuropathic Facial Pain

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