Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

Effect of Motor Cortex Stimulation by Concentric Electrode Transcranial Direct Current Stimulation on Chemotherapy Induced Peripheral Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833920
• Other study ID #: 539
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: June 2022

Study information

• Verified date: April 2021
• Source: Assiut University
• Contact: Shereen M Kamal, Associate professor
• Phone: 01006279209
• Email: sheridouh79[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: June 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Device:
• transcranial dirrect current brain stimuation
tDCS (2 mA) targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days (one session /day),

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in the visual analogue scale	patient describe his pain scored from 0 to 10 where 0=no pain and 10=the worst pain imaginable	0 (prestimulation), on the 5th day, 15th days and one month after the last session
Secondary	changes in the Leeds Assessment of neuropathic Symptoms and signs (LANSS)	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	0 (prestimulation),on the 5th day, 15th days and one month after the last session