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

NCT01849796 | Terminated Phase 2

• 1 other identifier: 148-10
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.)

Conditions

Facial Pain

Keywords

tDCS; Neuropathic; Facial; Pain; Neuralgia; deafferentation; Trigeminal

Outcome Measures

Primary Outcomes (1)

• 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.

  Daily from Baseline to up to 17 weeks

Study Arms (2)

Group A: Anodal tDCS

ACTIVE COMPARATOR

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

Device: tDCS

Arm B: Cathodal tDCS

SHAM COMPARATOR

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

Device: tDCS

Interventions

tDCS DEVICE

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.

Arm B: Cathodal tDCS; Group A: Anodal tDCS

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Medical Center: lead

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10033, United States

Location

MeSH Terms

Conditions

Facial Pain; Facies; Pain; Neuralgia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Joy Hao, MD

  Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2012
• First Posted: May 9, 2013
• Study Start: October 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 10, 2015

Record last verified: 2015-12

Locations

US (1)