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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01849796
First received: December 27, 2012
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.)


Condition Intervention Phase
Facial Pain
Device: tDCS
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Stimulation (TDCS) For The Treatment of Neuropathic Facial Pain.

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • Primary outcome will be a composite measure "Pain intensity/consumption of pain medication". [ Time Frame: Daily from Baseline to up to 17 weeks ] [ Designated as safety issue: No ]
    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:
  • Quality of Life-Physical Health [ Time Frame: Baseline, one week and four weeks after the end of each block of treatment. ] [ Designated as safety issue: No ]
  • Quality of Life-Mental Health [ Time Frame: Baseline, one week and four weeks after the end of each block of treatment ] [ Designated as safety issue: No ]
  • Quality of Sleep [ Time Frame: Baseline, one week and four weeks after the end of each block of treatment ] [ Designated as safety issue: No ]
  • Pain Interference with Facial Funtion [ Time Frame: Baseline, one week and four weeks after the end of each block of treatment ] [ Designated as safety issue: No ]
  • Pain Interference with Daily Activities [ Time Frame: Baseline, one week and four weeks after the end of each block of treatment ] [ Designated as safety issue: No ]
  • Neuropathic Pain Characteristics [ Time Frame: Baseline, one week and four weeks after the end of each block of treatment ] [ Designated as safety issue: No ]
    Neuropathic pain may be associated with abnormal sensations called dysesthesia, and pain produced by normally non-painful stimuli (allodynia). Common qualities include burning or coldness, "pins and needles" sensations, numbness and itching

  • Duration of Pain Relief [ Time Frame: Baseline, one week and four weeks after the end of each block of treatment ] [ Designated as safety issue: No ]
  • Occurence of Side Effects [ Time Frame: time of occurrence ] [ Designated as safety issue: Yes ]
    The outcome "Occurrence of Side Effects" will be captured at the time of occurrence in study reords (CRF and Source Documentation) and in patient's daily records, so called daily diaries.


Estimated Enrollment: 40
Study Start Date: October 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A: Anodal tDCS
Group A will receive one block of real excitatory anodal tDCS over the motor cortex and one block of sham.
Device: tDCS
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.
Sham Comparator: Arm B: Cathodal tDCS
Group B will receive one block of inhibitory cathodal tDCS over the somatosensory cortex and one block of sham.
Device: tDCS
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01849796

Locations
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10033
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
Principal Investigator: Joy Hao, MD Beth Israel Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01849796     History of Changes
Other Study ID Numbers: 148-10
Study First Received: December 27, 2012
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Medical Center:
tDCS
Neuropathic
Facial
Pain
Neuralgia
deafferentation
Trigeminal

Additional relevant MeSH terms:
Facies
Facial Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014