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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948050
• Other study ID #: 038-08
• Status: Completed
• Phase: N/A
• First received: August 20, 2013
• Last updated: June 13, 2014
• Start date: January 2009
• Est. completion date: November 2012

Study information

• Verified date: June 2014
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Pain

Intervention

Device:
• non-invasive transcranial direct current stimulation (tDCS)

Locations

Country	Name	City	State
United States	Beth Isael Medical Center	New York, USA	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No