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Completed

NCT Number: NCT02078479

rTMS as a Treatment of Neuropathic Pain Secondary to Malignancy

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.

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Key information

Conditions

Malignancy Agnosia Neoplasms Nervous System Diseases Neuralgia Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Procedure

Primary outcomes

  1. Neuropathic pain improvement

    Time frame: one month

    Reduction of neuropathic pain in patients with malignancy measured by VDS, VAS, LANSS.

Secondary outcomes

  1. Reduction of depression manifestation

    Time frame: one month

    Measurement of depression by using (HAM-D) scale.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain Secondary to Malignancy.

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 5, 2014
Registry last updated
Mar 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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