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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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.)

Detailed Summary: 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.
Sponsor: Beth Israel Medical Center

Current Primary Outcome: Primary outcome will be a composite measure "Pain intensity/consumption of pain medication". [ Time Frame: Daily from Baseline to up to 17 weeks ]

The washout period between phase I and phase II of the study is variable as patients have to go back to their baseline.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

  • Quality of Life-Physical Health [ Time Frame: Baseline, one week and four weeks after the end of each block of treatment. ]
  • Quality of Life-Mental Health [ Time Frame: Baseline, one week and four weeks after the end of each block of treatment ]
  • Quality of Sleep [ Time Frame: Baseline, one week and four weeks after the end of each block of treatment ]
  • Pain Interference with Facial Funtion [ Time Frame: Baseline, one week and four weeks after the end of each block of treatment ]
  • Pain Interference with Daily Activities [ Time Frame: Baseline, one week and four weeks after the end of each block of treatment ]
  • Neuropathic Pain Characteristics [ Time Frame: Baseline, one week and four weeks after the end of each block of treatment ]
  • Duration of Pain Relief [ Time Frame: Baseline, one week and four weeks after the end of each block of treatment ]
  • Occurence of Side Effects [ Time Frame: time of occurrence ]
    The outcome "Occurrence of Side Effects" will be captured at the time of occurrence in study reords (CRF and Source Documentation) and in patient's daily records, so called daily diaries.


Information By: Beth Israel Medical Center

Dates:
Date Received: December 27, 2012
Date Started: October 2010
Date Completion:
Last Updated: December 9, 2015
Last Verified: December 2015