rTMS as a Treatment of Neuropathic Pain Secondary to Malignancy

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02078479

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Malignancy	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).	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain Secondary to Malignancy.

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Real rTMS 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).
Sham Comparator: Sham rTMS 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).

Arm

Intervention/Treatment

Active Comparator: Real rTMS

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).

Sham Comparator: Sham rTMS

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).

Outcome Measures

Primary Outcome Measures

Neuropathic pain improvement [one month]
Reduction of neuropathic pain in patients with malignancy measured by VDS, VAS, LANSS.

Secondary Outcome Measures

Reduction of depression manifestation [one month]
Measurement of depression by using (HAM-D) scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

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.