rTMS as a Treatment of Visceral Pain Secondary to Malignancy

NCT02092805 | Completed

• 1 other identifier: rTMS in malig. visceral pain
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Malignancy

Keywords

VAS; VDS; HAM-D; Visceral pain; Malignancy; rTMS; Motor cortex; Analgesia; Dynorphin

Outcome Measures

Primary Outcomes (1)

• Visceral pain improvement

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

  one month

Secondary Outcomes (1)

• Reduction of depression manifestation

  one month

Study Arms (2)

Sham rTMS

SHAM COMPARATOR

Sham-rTMS was applied using the same parameters but with the coil elevated and angled away from the head to reproduce some of subjective sensation of rTMS.

Procedure: Sham rTMS (same parameters but with coil elevated and angled away from the head) every day for 10 consecutive days (5 days/week).

Real rTMS

ACTIVE COMPARATOR

The active group recieved real-rTMS over the motor cortical area corresponding to the hand of painful side. Each train consist of 2000 pulses at 20 Hz and 80% RMT (total duration 10s). The treatment was repeated every day for 5 consecutive days in week for two weeks (the total number of sessions had be given was 10 sessions).

Procedure: 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)

Interventions

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

Real rTMS

Sham rTMS (same parameters but with coil elevated and angled away from the head) every day for 10 consecutive days (5 days/week). PROCEDURE

Sham rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Neoplasms; Visceral Pain; Agnosia; Spinocerebellar ataxia 23

Condition Hierarchy (Ancestors)

Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical rofessor

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: March 20, 2014
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 20, 2014

Record last verified: 2014-03