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

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Isael Medical Center

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-invasive transcranial direct current stimulation (tDCS)

Device

Primary outcomes

Pain Intensity

Time frame: Assessed at baseline and post tDCS stimulation day 5

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).

Sponsors and collaborators

Lead sponsor

Beth Israel Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Sep 23, 2013
Registry last updated: Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed