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Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT04833920
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Shereen Mamdouh, Assiut University

Study Description
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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)

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy Device: transcranial dirrect current brain stimuation Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Motor Cortex Stimulation by Concentric Electrode Transcranial Direct Current Stimulation on Chemotherapy Induced Peripheral Neuropathy
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2022

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 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),
Sham Comparator: 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
 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),


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. changes in the Leeds Assessment of neuropathic Symptoms and signs (LANSS) [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04833920


Contacts
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Contact: Shereen M Kamal, Associate professor 01006279209 sheridouh79@yahoo.com

Locations
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Egypt
South Egypt Cancer Institute Recruiting
Assiut, Egypt, 11715
Contact: Shereen M Kamal, Lecturer    01006279209    sheridouh79@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Shereen M Kamal, Associate Professor Assiut University
More Information
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Responsible Party: Shereen Mamdouh, Associate professor, Assiut University
ClinicalTrials.gov Identifier: NCT04833920    
Other Study ID Numbers: 539
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shereen Mamdouh, Assiut University:
brain stimulation
chemotherapy induced peripheral neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases