Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy
Effect of Motor Cortex Stimulation by Concentric Electrode Transcranial Direct Current Stimulation on Chemotherapy Induced Peripheral Neuropathy
1 other identifier
interventional
26
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 2, 2021
CompletedFirst Posted
Study publicly available on registry
April 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedApril 6, 2021
April 1, 2021
9 months
April 2, 2021
April 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
active tDCS
ACTIVE COMPARATORtDCS targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days
sham tDCS
SHAM COMPARATORtDCS 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
Interventions
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),
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Egypt Cancer Institute
Asyut, 11715, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Shereen M Kamal, Associate Professor
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
April 2, 2021
First Posted
April 6, 2021
Study Start
April 1, 2021
Primary Completion
January 1, 2022
Study Completion
June 1, 2022
Last Updated
April 6, 2021
Record last verified: 2021-04