rTMS as a Treatment of Visceral Pain Secondary to Malignancy

Malignancy Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation in Visceral Pain Secondary to Malignancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092805
• Other study ID #: rTMS in malig. visceral pain
• Status: Completed
• Phase: N/A
• First received: March 19, 2014
• Last updated: March 19, 2014
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: March 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Malignancy
• Neoplasms
• Visceral Pain

Intervention

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)

• Sham rTMS (same parameters but with coil elevated and angled away from the head) every day for 10 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	Visceral pain improvement	Reduction of visceral pain in patients with malignancy measured by VAS, VDS.	one month	No
Secondary	Reduction of depression manifestation	Measurement of depression by using (HAM-D) scale.	one month	No