Status:
TERMINATED
Transcranial Stimulation (tDCS) For the Treatment of Neuropathic Facial Pain
Lead Sponsor:
Beth Israel Medical Center
Conditions:
Facial Pain
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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 (inh...
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 compa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01849796
Start Date
October 1 2010
End Date
December 1 2013
Last Update
December 10 2015
Active Locations (1)
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1
Beth Israel Medical Center
New York, New York, United States, 10033