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

NCT ID: NCT01948050

Last Updated: 2014-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-11-30

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

real tDCS stimulation

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

Group Type: EXPERIMENTAL

non-invasive transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

Sham tDCS

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.

Group Type: SHAM_COMPARATOR

non-invasive transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

Interventions

non-invasive transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helena Knotkova, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Medical Center

Locations

Beth Isael Medical Center

New York, USA, New York, United States

Countries

United States

Other Identifiers

038-08

Identifier Type: -

Identifier Source: org_study_id