to investigate the analgesic effect of high frequency 10 Hz rTMS on experimental pain measured through quantitative sensory testing (QST) in healthy subjects.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Pijn, Centraal Zenuwstelsel: Verwerking van pijn.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Analgesic effect is measured through QST. QST measurements will be performed
using different modalities, e.g. mechanical pressure, electrical stimulation
and conditioned pain modulation (CPM). The primary outcome is pressure pain
threshold (PPT).
Secondary outcome
Secondary outcomes are: Electric Sensation Threshold in mA, Electric Pain
Threshold in mA, Electric Pain Tolerance Threshold in mA, Conditioned Pain
Modulation Paradigm in kPa for PPT and mA for EPPT and VAS-score (0-10). Mask
validity tests in % (for both rTMS and sham).
And Adverse events.
Background summary
Management of chronic pain showed to be generally unsatisfactory In the search
for alternative pain treatments, there is accumulating evidence that repetitive
transcranial magnetic stimulation (rTMS) is able to produce an analgesic effect
in patients. Single dose high-frequency rTMS of the motor cortex shows a small
short-term effect on chronic pain. However, the heterogeneity in rTMS studies
is highly significant and the evidence of these studies is of low-quality
because of bias risk. Additionally, rTMS showed earlier to be a predictor for
the effective different neurosurgical brain stimulating technique, motor cortex
stimulation (MCS). The lack of effective chronic pain treatment, the possible
predicting quality of rTMS for and promising results of MCS, the promising
results of high frequency repetitive transcranial stimulation of the motor
cortex, and the lack of studies with a high quality study design form the basis
of the present research proposal.
Study objective
to investigate the analgesic effect of high frequency 10 Hz rTMS on
experimental pain measured through quantitative sensory testing (QST) in
healthy subjects.
Study design
A pilot study using a randomized, double-blind, sham-controlled, cross-over
design.
Intervention
All subjects participate in two conditions in random sequence. These conditions
contain either sham rTMS or active 10Hz rTMS. The rTMS is 10 Hz high frequency
rTMS, stimulating the motor cortex with 80% of the resting motor threshold in a
single session with a total of 3000 pulses.
Study burden and risks
Participation results in a total of 3 contacts of which 2 are visits and 1 is a
telephone interview. After visit 1, including screening, the time from visit 1
to the final telephone interview will be 2 weeks. All visits will take place in
the outpatient clinic of the Radboud University Medical Centre in Nijmegen, the
*RadboudUMC*.
The participating subjects will obtain no direct personal benefit.
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
1. Subject is or is older than 18 years.
2. Subjects should be naïve to rTMS treatment
Exclusion criteria
1. Subject has an condition with risk of magnetic interference while using rTMS.
2. Subject has an condition with increased or uncertain risk of inducing epileptic seizures while using rTMS(active or history of epilepsy, lesions of the brain, interfering drugs/medication)
3. Subject has an conditions with increased risk of other events while using rTMS (pregnancy, severe hearth disease)
3. Subject has an history of, clinical signs/symptoms of, or concomitant acute or chronic pain.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56046.091.16 |