Skip to main content
OpenTrials
Completed

NCT Number: NCT02092805

rTMS as a Treatment of Visceral Pain Secondary to Malignancy

The purpose of this study is to assess the efficacy of rTMS over primary motor cortex in patients suffering from malignant visceral pain. Thirty four patients were included in the study. They are divided randomly into 2 groups using closed envelop as real rTMS group and sham group. Real rTMS over the hand area of motor cortex (20 Hz, 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) and the coil elevated and angled away from the head as sham stimulation. Patients were evaluated by verbal descriptor scale (VDS), visual analog scale (VAS), and Hamilton rating scale for depression (HAM-D) at the baseline, after 1st, 5th, 10th session, 15 day and 1 month after end of sessions. Serum human dynorphin (Dyn) level was measured at baseline, 5th and 10th session.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malignancy Agnosia Neoplasms Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nociceptive Pain Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Spinocerebellar ataxia 23 Visceral Pain

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 visceral pain resistant to medical treatment for at least 2 months or associated with significant adverse effect from medication was involved in this study.

Exclusion criteria

  • We excluded patients with intracranial metallic devices or with pacemakers or any other device. We also excluded those with extensive myocardial ischemia, unstable angina and those known to have epilepsy.

Treatment and study plan

Real rTMS(20 Hz, 10 trains, inter train interval 30 sc with total pulses 2000, intensity 80% of motor threshold) 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 10 consecutive days (5 days/week).

Procedure

Primary outcomes

  1. Visceral pain improvement

    Time frame: one month

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

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 Visceral Pain Secondary to Malignancy

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 20, 2014
Registry last updated
Mar 20, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.