The Effect of Transcranial Direct Current Stimulation (t-DCS) On the P300 Component of Event-Related Potentials in Patients With Chronic Neuropathic Pain Due To CRPS or Diabetic Neuropathy

Soroka University Medical Center

Status: Withdrawn

Conditions: Chemotherapy Induced Pain Neuropathy; Complex Regional Pain Syndrome Type II; Diabetic Neuropathies; Resistant Peripheral Neuropathic Pain

Treatments: Device: TDCS/sham procedure on five consecutive days

Study type: Interventional

Funder types: Other

Identifiers

NCT00815932

SOR477808CTIL

Details and patient eligibility

About

This is a controlled trial designed to determine short- and long-term effects of repeated tDCS on the P300 component of event-related evoked potentials in patients with chronic neuropathic pain due to Complex regional Pain Syndrome (CRPS) or diabetic neuropathy as compared with healthy subjects.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• An affected upper limb or lower limb

• Diagnosed as : Diabetic neuropathy, Complex Regional Pain Syndrome (CRPS), Chemotherapy Induced Pain Neuropathy (CIPN), Peripheral Neuropathy.

• Have not responded to at least two medications of the following groups: Opioids. Tricyclics, SSRI, SNRI, Pregabalin, Gabapentin, Anticonvulsants.

• Positive LANSS or CRPS criteria as follows:

  1. Continuing pain which is disproportionate to any inciting event or for CRPS diagnosis.
  2. Must report at least one symptom (symptoms here are reports by subject) in each of the four following categories: sensory, vasomotor, sudomotor/edema, motor/trophic.
  3. Must display at least one sign (signs here refer to objective observation/testing) in in each of the four following categories: sensory, vasomotor, sudomotor/edema, motor/trophic;

• Must meet resistant neuropathic pain criteria - pain that is neuropathic in characters that at least two neuropathic medications not from the same group have been tried for at least a month without improvement or severe side-effects were experienced. Resistant neuropathic pain with a score for "average pain in the last 24 hours" ≥4 on a numeric scale 0-10

• tDCS naive

Exclusion criteria

• Serious health problems other than CRPS or resistant neuropathic pain (e.g. uncontrolled hypertension, uncontrolled diabetes, heart failure)
• Pain/painful conditions unrelated to CRPS or neuropathic pain
• Pregnancy
• History of seizures/epilepsy
• Implanted device (e.g. pacemaker)
• Active illicit drug/alcohol abuse
• Unable to follow directions or complete tools in Hebrew
• Previous exposure to tDCS stimulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 4 patient groups

1-CRPS

Experimental group

Description:

10 tDCS naïve patients with CRPS-related neuropathic pain in upper limb

Treatment:

Device: TDCS/sham procedure on five consecutive days

2-DN

Experimental group

Description:

20 tDCS naïve patients with diabetic neuropathy

Treatment:

Device: TDCS/sham procedure on five consecutive days

3-RPNP

Experimental group

Description:

20 tDCS naïve patients with resistant peripheral neuropathic pain

Treatment:

Device: TDCS/sham procedure on five consecutive days

4-CIPN

Experimental group

Description:

10 tDCS naïve patients with CIPN-Chemotherapy Induced Pain Neuropathy patients

Treatment:

Device: TDCS/sham procedure on five consecutive days