Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy
Study Details
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
Primary Outcome Measures
- changes in the visual analogue scale [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
- 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]
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
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,
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brain cancer or metastasis and
-
those known to have epilepsy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | South Egypt Cancer Institute | Assiut | Egypt | 11715 |
Sponsors and Collaborators
- Assiut University
Investigators
- Principal Investigator: Shereen M Kamal, Associate Professor, Assiut University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 539