Clinical trial NCT01849796: Transcranial Stimulation (tDCS) For the Treatment of Neuropathic Facial Pain
Official title: Transcranial Stimulation (TDCS) For The Treatment of Neuropathic Facial Pain.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Facial Pain
Keywords: tDCS
Neuropathic
Facial
Pain
Neuralgia
deafferentation
Trigeminal
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Primary outcome will be a composite measure "Pain intensity/consumption of pain medication".
timeFrame: Daily from Baseline to up to 17 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Joy Hao, MD
role: PRINCIPAL_INVESTIGATOR
References: