Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy

Not Applicable

• Conditions: Chemotherapy-induced Peripheral Neuropathy

• Registration Number: NCT04833920
• Lead Sponsor: Assiut University

Brief Summary

Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin)

Detailed Description

Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin) . CIPN is one of several long term side effects of anticancer medications that can appear during and after treatment. CIPN symptoms include pain, dysesthesia, motor and sensory disorders. CIPN can also be insufficiently responsive to pharmaceutical therapy similar to other types of refractory neuropathic pain This study is designed to evaluate the effect of two concentric electrode transcranial direct current stimulation (CE-tDCS) over the primary motor cortex (M) in management of chemotherapy induced peripheral neuropathy.

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-01
• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-03
• Last Update Submitted: 2021-04-03
• Study First Posted: 2021-04-06
• Last Update Posted: 2021-04-06
• Primary Completion: 2022-01
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• any stage of cancer, with a confirmed treatment plan consisting of taxane-based or oxaliplatin-based chemotherapy, neuropathic pain and/or peripheral sensory neuropathy with VAS score ≥ 3 that are resistant to medical treatment

Exclusion Criteria

• patients with intracranial metallic devices or with pacemakers or any other device. - -W those with extensive myocardial ischemia,
• higher brain dysfunction,
• migraine headache,
• brain cancer or metastasis and
• those known to have epilepsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
changes in the visual analogue scale	0 (prestimulation), on the 5th day, 15th days and one month after the last session	patient describe his pain scored from 0 to 10 where 0=no pain and 10=the worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
changes in the Leeds Assessment of neuropathic Symptoms and signs (LANSS)	0 (prestimulation),on the 5th day, 15th days and one month after the last session	the patients will be asked to describe his pain by answering questions in yes or no; score ≥ 12 suggests neuropathic pain is likely to be involved and score \< 12 suggests that neuropathic pain is unlikely to be involved

Trial Locations

Locations (1)

South Egypt Cancer Institute; 🇪🇬 Assiut, Egypt