A Phase 2 interventional study of tDCS in Facial Pain, sponsored by Beth Israel Medical Center. Terminated at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-10.
Sponsored by Beth Israel Medical Center · Phase 2, Interventional, and Treatment
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.)
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.
217 studies on the registry are indexed under Facies; 35 are open to participants now.
This study's enrollment of 21 is below the median of 40 across 162 interventional studies indexed under Facies.
Browse Facies studies →Beth Israel Medical Center is the lead sponsor of 50 studies on the registry; none are open to participants now.
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Spontaneous facial neuropathic pain due to any of following:
e) Postherpetic neuralgia, (PHN): facial pain resulting from trigeminal Herpes zoster (shingles) outbreak in the trigeminal distribution.
Exclusion Criteria:
Group A will receive one block of real excitatory anodal tDCS over the motor cortex and one block of sham.
Device: tDCS
Group B will receive one block of inhibitory cathodal tDCS over the somatosensory cortex and one block of sham.
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.
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.
Time frame: Daily from Baseline to up to 17 weeks
This study is terminated, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Beth Israel Medical Center