Back to resultsEffect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy
Primary Purpose
Chemotherapy-induced Peripheral Neuropathy
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
transcranial dirrect current brain stimuation
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring brain stimulation, chemotherapy induced peripheral neuropathy
Eligibility Criteria
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
Sites / Locations
- South Egypt Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
active tDCS
sham tDCS
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04833920
Brief Title
Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy
Official Title
Effect of Motor Cortex Stimulation by Concentric Electrode Transcranial Direct Current Stimulation on Chemotherapy Induced Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy
Keywords
brain stimulation, chemotherapy induced peripheral neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active tDCS
Arm Type
Active Comparator
Arm Description
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
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
transcranial dirrect current brain stimuation
Intervention Description
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),
Primary Outcome Measure Information:
Title
changes in the visual analogue scale
Description
patient describe his pain scored from 0 to 10 where 0=no pain and 10=the worst pain imaginable
Time Frame
0 (prestimulation), on the 5th day, 15th days and one month after the last session
Secondary Outcome Measure Information:
Title
changes in the Leeds Assessment of neuropathic Symptoms and signs (LANSS)
Description
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
Time Frame
0 (prestimulation),on the 5th day, 15th days and one month after the last session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shereen M Kamal, Associate professor
Phone
01006279209
Email
sheridouh79@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shereen M Kamal, Associate Professor
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Egypt Cancer Institute
City
Assiut
ZIP/Postal Code
11715
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shereen M Kamal, Lecturer
Phone
01006279209
Email
sheridouh79@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy
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