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

NCT01948050 | Completed Results

• 1 other identifier: 038-08
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

real tDCS stimulation

EXPERIMENTAL

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)

Sham tDCS

SHAM COMPARATOR

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)

Interventions

non-invasive transcranial direct current stimulation (tDCS) DEVICE

Sham tDCS; real tDCS stimulation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Beth Israel Medical Center: lead

Study Sites (1)

Beth Isael Medical Center

New York, USA, New York, 10003, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Helena Knotkova, PhD
• Organization: Beth Israel Medical Center

hknotkov@chpnet.org

212-844-8541

Study Officials

• Helena Knotkova, PhD

  Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: September 23, 2013
• Study Start: January 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 14, 2014
• Results First Posted: July 14, 2014

Record last verified: 2014-06

Locations

US (1)