Effect of Motor Cortex Stimulation by Concentric Electrode Transcranial Direct Current Stimulation on Chemotherapy Induced Peripheral Neuropathy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Assiut University
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- changes in the visual analogue scale
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
active tDCS
tDCS targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days
Intervention: transcranial dirrect current brain stimuation (Device)
sham tDCS
tDCS over the primary motor cortex in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds
Intervention: transcranial dirrect current brain stimuation (Device)
Outcomes
Primary Outcomes
changes in the visual analogue scale
Time Frame: 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 Outcomes
- 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)
Investigators
Shereen Mamdouh
Associate professor
Assiut University