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

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
non-invasive transcranial direct current stimulation (tDCS)
Sponsored by
Beth Israel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Isael Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

real tDCS stimulation

Sham tDCS

Arm Description

non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
August 20, 2013
Last Updated
June 13, 2014
Sponsor
Beth Israel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01948050
Brief Title
Pilot Study of Transcranial Stimulation (tDCS)to Relieve Neuropathic Pain in Cancer Patients
Official Title
Pilot Study on Safety and Efficacy of the Non-invasive Transcranial Stimulation (tDCS) to Relieve Neuropathic Pain in Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
real tDCS stimulation
Arm Type
Experimental
Arm Description
non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
non-invasive transcranial direct current stimulation (tDCS)
Primary Outcome Measure Information:
Title
Pain Intensity
Description
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).
Time Frame
Assessed at baseline and post tDCS stimulation day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena Knotkova, PhD
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Isael Medical Center
City
New York, USA
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

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

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