Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02078479
Other study ID # rTMS with malignancy pain
Secondary ID
Status Completed
Phase N/A
First received March 1, 2014
Last updated March 1, 2014
Start date January 2010
Est. completion date May 2013

Study information

Verified date February 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 isto assess the efficacy of daily 10 sessions of rTMS over primary motor cortex in patients suffering from malignant neuropathic pain. Thirty four patients were divided randomly into 2 groups equally using closed envelops to undergo real (20 Hz, 10 second, 10 trains with inter-train interval 30 second with total pulses 2000, intensity 80% of motor threshold over hand area of motor cortex) or sham rTMS (same parameters but with coil elevated and angled away from the head)every day for ten consecutive days (5 days/week). Patients were evaluated using a verbal descriptor scale (VDS), visual analog scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS) and Hamilton rating scale for depression (HAM-D) at baseline, after 1st, 5th, 10thtreatment session, and then 15 days and 1 month after the end of treatment. ic pain.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

All patients within age group 18-65 years with malignant lateralized neuropathic pain resistant to medical treatment for at least 2 months or associated with significant adverse effects from medication were involved in this study.

Exclusion Criteria:

Patients with intracranial metallic devices Patients with pacemakers or any other device. Patients with recent myocardial ischemia, unstable angina Patients known to have history of epilepsy.

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
20 Hz, 10 s, 10 trains with inter-train interval 30 s 2000 pulses , intensity 80% over hand area 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 ten 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 Neuropathic pain improvement Reduction of neuropathic pain in patients with malignancy measured by VDS, VAS, LANSS. one month No
Secondary Reduction of depression manifestation Measurement of depression by using (HAM-D) scale. one month No
See also
  Status Clinical Trial Phase
Recruiting NCT05640115 - Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent Early Phase 1
Recruiting NCT02891642 - Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid
Completed NCT02282449 - Power Injectable Versus a Non-Power Injectable, Upper Arm, TIVAD for Chemotherapy N/A
Completed NCT01212731 - Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study
Completed NCT01199822 - Study of the Safety and Pharmacokinetics of IMC-3G3 in Japanese Patients With Solid Tumors Phase 1
Recruiting NCT04122469 - The Role of Stereo-tActic BoDy RadIotherApy iN Oligo-Progressive MalignanT Disease N/A
Recruiting NCT03561727 - Risk Factors for Development of Incisional Hernia in Transverse Incisions N/A
Terminated NCT03251924 - A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03997968 - A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT00092222 - Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity Phase 2
Recruiting NCT05770102 - DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Teenage/Young Adults and Paediatric Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition Phase 2/Phase 3
Recruiting NCT05886764 - Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials N/A
Not yet recruiting NCT05992363 - Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction Phase 3
Recruiting NCT05761366 - Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor Phase 2
Recruiting NCT04887545 - Immune- and Microenvironment- Proteogenomics Profiling for Classifying Lung Cancer Patients
Completed NCT03061955 - Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)
Completed NCT03909464 - Non-Invasive Neurosensory Testing For Chemotherapy-Induced Peripheral Neuropathy
Active, not recruiting NCT02649491 - Using an Electronic Nose to Predict Gastrointestinal Consequences of Pelvic Radiotherapy N/A
Recruiting NCT02776995 - Tumor Monitoring Using Thermography During Radiation Therapy N/A
Active, not recruiting NCT01242072 - Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies Phase 1