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

Facial Pain Clinical Trial

— TDCS  

Official title:

Transcranial Stimulation (TDCS) For The Treatment of Neuropathic Facial Pain.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01849796
• Other study ID #: 148-10
• Status: Terminated
• Phase: Phase 2
• First received: December 27, 2012
• Last updated: December 9, 2015
• Start date: October 2010
• Est. completion date: December 2013

Study information

• Verified date: December 2015
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Pain
• Facies

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Department of Pain Medicine and Palliative Care