rTMS as a Treatment of Visceral Pain Secondary to Malignancy

NCT ID: NCT02092805

Last Updated: 2014-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sham rTMS

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.

Group Type: SHAM_COMPARATOR

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

Intervention Type: PROCEDURE

Real rTMS

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).

Group Type: ACTIVE_COMPARATOR

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)

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Eman M. Khedr

Clinical rofessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

rTMS in malig. visceral pain

Identifier Type: -

Identifier Source: org_study_id