rTMS as a Treatment of Neuropathic Pain Secondary to Malignancy

Malignancy Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain Secondary to Malignancy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078479
• Other study ID #: rTMS with malignancy pain
• Status: Completed
• Phase: N/A
• First received: March 1, 2014
• Last updated: March 1, 2014
• Start date: January 2010
• Est. completion date: May 2013

Study information

• Verified date: February 2014
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignancy
• Neoplasms
• Neuralgia

Intervention

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 rTMS (same parameters but with coil elevated and angled away from the head)every day for ten consecutive days (5 days/week).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropathic pain improvement	Reduction of neuropathic pain in patients with malignancy measured by VDS, VAS, LANSS.	one month	No
Secondary	Reduction of depression manifestation	Measurement of depression by using (HAM-D) scale.	one month	No