rTMS as a Treatment of Neuropathic Pain Secondary to Malignancy

Study Overview
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Brief Summary
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The purpose of this study isto assess the efficacy of daily 10 sessions of rTMS over primary motor cortex in patients suffering from malignant neuropathic pain. Thirty four patients were divided randomly into 2 groups equally using closed envelops to undergo real (20 Hz, 10 second, 10 trains with inter-train interval 30 second with total pulses 2000, intensity 80% of motor threshold over hand area of motor cortex) or sham rTMS (same parameters but with coil elevated and angled away from the head)every day for ten consecutive days (5 days/week). Patients were evaluated using a verbal descriptor scale (VDS), visual analog scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS) and Hamilton rating scale for depression (HAM-D) at baseline, after 1st, 5th, 10thtreatment session, and then 15 days and 1 month after the end of treatment. ic pain.

Official Title
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Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain Secondary to Malignancy.

Conditions
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Malignancy

Intervention / Treatment
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* Procedure: 20 Hz, 10 s, 10 trains with inter-train interval 30 s 2000 pulses , intensity 80% over hand area daily for 10 consecutive days (5 days/week).
* Procedure: sham rTMS (same parameters but with coil elevated and angled away from the head)every day for ten consecutive days (5 days/week).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients within age group 18-65 years with malignant lateralized neuropathic pain resistant to medical treatment for at least 2 months or associated with significant adverse effects from medication were involved in this study. Exclusion Criteria: Patients with intracranial metallic devices Patients with pacemakers or any other device. Patients with recent myocardial ischemia, unstable angina Patients known to have history of epilepsy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real rTMS<br>The active group received Real rTMS over the hand area of motor cortex (20 Hz, 10 second, 10 trains with inter-train interval 30 second with total pulses 2000, intensity 80% of motor threshold) every day for ten consecutive days (5 days/week). | Procedure: 20 Hz, 10 s, 10 trains with inter-train interval 30 s 2000 pulses , intensity 80% over hand area daily for 10 consecutive days (5 days/week).<br> <br> |
| Sham Comparator: Sham rTMS<br>Sham-rTMS was applied using the same parameters but with the coil elevated and angled away from the head to reproduce the same of subjective sensation of rTMS | Procedure: sham rTMS (same parameters but with coil elevated and angled away from the head)every day for ten consecutive days (5 days/week).<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropathic pain improvement | Reduction of neuropathic pain in patients with malignancy measured by VDS, VAS, LANSS. | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of depression manifestation | Measurement of depression by using (HAM-D) scale. | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motor cortex, analgesia, Malignancy, VAS, LANSS, VDS, Neuropathic pain, rTMS