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rTMS as a Treatment of Visceral Pain Secondary to Malignancy

Repetitive Transcranial Magnetic Stimulation in Visceral Pain Secondary to Malignancy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02092805
Enrollment
34
Registered
2014-03-20
Start date
2010-01-31
Completion date
2012-01-31
Last updated
2014-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignancy

Keywords

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

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.

Interventions

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Visceral pain improvementone monthReduction of visceral pain in patients with malignancy measured by VAS, VDS.

Secondary

MeasureTime frameDescription
Reduction of depression manifestationone monthMeasurement of depression by using (HAM-D) scale.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026