Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-06-30

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Chemotherapy-induced Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

transcranial dirrect current brain stimuation

Intervention Type DEVICE

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),

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

Group Type SHAM_COMPARATOR

transcranial dirrect current brain stimuation

Intervention Type DEVICE

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),

Interventions

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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),

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No