Study Stopped
Insufficient recruitment
Analgesic Effect of rTMS in Vasculitic Neuropathy
Analgesic Effect of Repetitive Transcranial Magnetic Stimulation in Painful Vasculitic Neuropathy
1 other identifier
interventional
3
1 country
1
Brief Summary
Vasculitic neuropathy (VN) results from inflammation and destruction of the walls of predominantly small vessels with subsequent ischemic damage of peripheral nerves. VN is painful in vast majority of patients and the pain is intractable with pharmacotherapy in about 40% of cases. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity and is regarded as one of alternative methods to alleviate pain associated with various kind of neuropathies. The purpose of this study is to compare the effectiveness of analgesic effect of rTMS in vasculitic neuropathy with sham stimulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedStudy Start
First participant enrolled
January 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2023
CompletedOctober 2, 2023
September 1, 2023
2.7 years
January 16, 2021
September 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Numeric Pain Severity Scale after rTMS
Total score 10, with higher scores representing more severe pain. Change from baseline score in the Numeric Pain Severity Scale to the measurement taken after finishing rTMS.
Before rTMS, immediately after (on same day) finishing rTMS.
Numeric Pain Severity Scale First Follow Up
Total score 10, with higher scores representing more severe pain. Change from baseline score in the Numeric Pain Severity Scale to the measurement taken two weeks after finishing rTMS.
Before rTMS, two weeks after finishing rTMS
Numeric Pain Severity Scale Second Follow Up
Total score 10, with higher scores representing more severe pain. Change from baseline score in the Numeric Pain Severity Scale to the measurement taken four weeks after finishing rTMS.
Before rTMS, four weeks after finishing rTMS
Visual Analog Scale of Pain Severity
An analog scale of the length of 100 milimeter. Total score of 100, with higher scores representing more severe pain. Change through the study.
Through study completion, an average of 10 weeks
Secondary Outcomes (33)
Hospital Anxiety and Depression Scale after rTMS
Before rTMS, immediately after (on same day) finishing rTMS.
Hospital Anxiety and Depression Scale First Follow Up
Before rTMS, two weeks after finishing rTMS
Hospital Anxiety and Depression Scale Second Follow Up
Before rTMS, four weeks after finishing rTMS
36-Item Short Form Health Survey after rTMS
Before rTMS, immediately after (on same day) finishing rTMS.
36-Item Short Form Health Survey First Follow Up
Before rTMS, two weeks after finishing rTMS
- +28 more secondary outcomes
Study Arms (2)
Active repetitive transcranial magnetic stimulation
EXPERIMENTAL10 hertz (Hz) rTMS will be administered over the primary motor area. Therapy will include 5 daily sessions (on consecutive week days). In every sessions 1500 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.
Sham repetitive transcranial magnetic stimulation
SHAM COMPARATORSham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
Interventions
High frequency rTMS over the primary motor area to induce the long term potentiation of primary motor areas for the muscles of upper extremity.
Sham stimulation to mimic the high frequency rTMS over the primary motor area.
Eligibility Criteria
You may qualify if:
- Diagnosis of vasculitic neuropathy
- Neuropathic pain of constant severity since not less than a month and requiring use of analgesics more than once a week
You may not qualify if:
- Severe depression
- Personality disorders and other psychiatric conditions, which could disturb the participation in the study
- Cognitive deficits, which could disturb the participation in the study
- Contraindications for rTMS as listed by the Guidelines of the International Federation of Clinical Neurophysiology (Rossi et al. 2009) i.e. seizure in the past, epilepsy, presence of magnetic material in the reach of magnetic field, pregnancy, likelihood to get pregnant, intracranial electrodes, cardiac pacemaker or intracardiac lines, frequent syncopes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jagiellonian University Medical College, Department of Neurology
Krakow, 31503, Poland
Related Publications (1)
Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
PMID: 19833552BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Justyna Brączyk, MS
Jagiellonian University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sham stimulation will be provided by holding the stimulating coil perpendicularly to the scalp, which assures similar impression as during active stimulation but prevents significant magnetic field to reach the brain tissue.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 16, 2021
First Posted
January 22, 2021
Study Start
January 25, 2021
Primary Completion
September 20, 2023
Study Completion
September 21, 2023
Last Updated
October 2, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The data will become available after the study results will be published.
- Access Criteria
- On request send by e-mail: jakub.antczak@uj.edu.pl
After completing the study, the age and gender of participants as well as the scores and results of all outcome measurements made at baseline, after rTMS, at the first and at the second follow up will be made available to other researchers on request.