MalignancyNCT02078479
rTMS as a Treatment of Neuropathic Pain Secondary to Malignancy
A study testing 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). in people with Malignancy, run by Assiut University.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malignancy
- What is being tested?
- 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).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain Secondary to Malignancy.
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.
- Conditions
- Malignancy
- Being tested
- 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).
- Keywords
- Malignancy, VAS, LANSS, VDS, Neuropathic pain, rTMS, motor cortex, analgesia
- Medical subject headings
- Neoplasms, Neuralgia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).Procedure or surgery
sham rTMS (same parameters but with coil elevated and angled away from the head)every day for ten consecutive days (5 days/week).Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Real rTMS | Active comparator | The active group received Real rTMS over the hand area of motor cortex (20 Hz, 10 second, 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). Receives: 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 | Sham comparator | Sham-rTMS was applied using the same parameters but with the coil elevated and angled away from the head to reproduce the same of subjective sensation of rTMS Receives: Procedure: sham rTMS (same parameters but with coil elevated and angled away from the head)every day for ten consecutive days (5 days/week). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic pain improvement
Reduction of neuropathic pain in patients with malignancy measured by VDS, VAS, LANSS.
Measured: one month
Secondary outcomes (1)
Reduction of depression manifestation
Measurement of depression by using (HAM-D) scale.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startJan 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman M. Khedr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078479
- Sponsor's protocol ID
- rTMS with malignancy pain
- Status last verified
- Feb 2014
- First submitted
- 1 Mar 2014
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain Secondary to Malignancy.
- ClinicalTrials.gov ID
- NCT02078479
- Acronym / sponsor ID
- rTMS with malignancy pain
- Conditions
- Malignancy
- Keywords
- Malignancy, VAS, LANSS, VDS, Neuropathic pain, rTMS, motor cortex, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real rTMS | Active comparator | 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).The active group received Real rTMS over the hand area of motor cortex (20 Hz, 10 second, 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). |
| Sham rTMS | Sham comparator | Procedure: sham rTMS (same parameters but with coil elevated and angled away from the head)every day for ten consecutive days (5 days/week).Sham-rTMS was applied using the same parameters but with the coil elevated and angled away from the head to reproduce the same of subjective sensation of rTMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | Real rTMS |
| sham rTMS (same parameters but with coil elevated and angled away from the head)every day for ten consecutive days (5 days/week). | Procedure or surgery | Sham rTMS |
Primary outcome
Neuropathic pain improvement
Time frame: one month
Reduction of neuropathic pain in patients with malignancy measured by VDS, VAS, LANSS.
1 secondary outcome
Reduction of depression manifestation
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 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). in people with Malignancy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic pain improvement (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.