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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study on Safety and Efficacy of the Non-invasive Transcranial Stimulation (tDCS) to Relieve Neuropathic Pain in Cancer Patients

Conditions
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Pain

Intervention / Treatment
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* Device: non-invasive transcranial direct current stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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Adult male and female patients with cancer who developed neuropathic pain in the affected area secondary the surgical procedure, chemotherapy or radiation that meet the following Inclusion/Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: real tDCS stimulation<br>non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days. | Device: non-invasive transcranial direct current stimulation (tDCS)<br> <br> |
| Sham Comparator: Sham tDCS<br>sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days. | Device: non-invasive transcranial direct current stimulation (tDCS)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | 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). | Assessed at baseline and post tDCS stimulation day 5 |