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

Beth Israel Lahey Health

Status: Completed

Conditions: Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01948050

038-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

real tDCS stimulation

Experimental group

Description:

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

Treatment:

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

Sham tDCS

Sham Comparator group

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.

Treatment:

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