Pilot Study of Transcranial Stimulation (tDCS)to Relieve Neuropathic Pain in Cancer Patients

Not Applicable

Completed

• Conditions: Pain

• Registration Number: NCT01948050
• Lead Sponsor: Beth Israel Medical Center

Brief 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 cancer patients who developed neuropathic pain in the affected area after a surgical intervention, radiation therapy, or chemotherapy to treat the disease.

Detailed Description

This is a pilot study that aims to determine the effect of repetitive tDCS stimulation, performed on five consecutive days at intensity of 2 mA, on pain and somatosensory abnormalities in patients with neuropathic pain that followed surgical, radiation or chemotherapeutic treatment, and to evaluate safety of tDCS in the same model.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2013-08-20
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-23
• Results First Submitted: 2014-02-24
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-13
• Last Update Submitted: 2014-06-13
• Results First Posted: 2014-07-14
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Pain on the side of the lesion

• Spontaneous pain with a score for "worst pain in the last 24 hours" >4 on a numeric scale 0-10

• Must present the following symptoms and signs:

  • Continuous burning, shooting, or lancinating pain.
  • Presence of hyperesthesia
  • Presence of hyperalgesia (to pinprick) and/or allodynia (to light touch)

Exclusion Criteria

• Uncontrolled hypertension, uncontrolled diabetes, uncontrolled cardiovascular disease
• Pain/painful conditions unrelated to the cancer or related treatment
• Pregnancy
• History of seizures/epilepsy
• Any implanted devices (e.g. a cardio stimulator, etc)
• Active illegal drug/alcohol abuse
• Unable to follow directions or complete tools in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Intensity	Assessed at baseline and post tDCS stimulation day 5	Measured on the 11 point numerical paid rating scale with anchor points 0 = no pain and 10 = worst pain possible. The outcome measure "Pain intensity" assessed as a change between baseline and post tDCS stimulation (after stimulation day 5). The calculated change in the range of positive numbers indicates decreased pain intensity post-treatment (eg. baseline 6; post treatment 4; change +2 indicating decrease of pain intensity by 2 points). Similarly, change in range of negative numbers indicates a worsening of pain intensity (eg. baseline 6; post treatment 8; change -2).

Trial Locations

Locations (1)

Beth Isael Medical Center; 🇺🇸 New York, USA, New York, United States