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

Beth Israel Lahey Health

Status and phase: Terminated; Phase 2

Conditions: Facial Pain

Treatments: Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT01849796

148-10

Details and patient eligibility

About

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.)

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

21 participants in 2 patient groups

Group A: Anodal tDCS

Active Comparator group

Description:

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

Treatment:

Device: tDCS

Arm B: Cathodal tDCS

Sham Comparator group

Description:

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

Treatment:

Device: tDCS