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Single-pulse transcranial magnetic stimulation for the assessment and changes of cortical motor maps in subjects with low back pain, compared to healthy subjects

Single-pulse transcranial magnetic stimulation for the assessment and changes of cortical motor maps in subjects with low back pain, compared to healthy subjects - Single-pulse TMS in LBP

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49299
Enrollment
50
Registered
2019-11-15
Start date
2019-10-01
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Musculoskeletale aandoeningen non-specific Low Back Pain recurrent a-specific low back pain

Interventions

None listed

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Participants experiencing episode of aspecific recurrent low back pain Healthy participants that never experienced low back pain or experienced low back pain more than 3 years ago Age 18-65 years Informed consent signed

Exclusion criteria

Exclusion criteria: (Family) history of epilepsy Neurological disorder Psychological disorder Use of (epileptogenic) medication Possessing a contraindication for single-pulse TMS (as determined by a TMS screening questionnaire: 'Fl . Screening Questionnaire

Design outcomes

Primary

MeasureTime frame
Corticospinal excitability (CSE) can be assessed using single-pulse TMS across the primary motor cortex (M1) with EMG surface electrodes placed on the target muscles of the contralateral limb. Stimulation of M1, at the site of representation of the target muscle, will elicit motor evoked potentials (MEPs) in the EMG signal. The peak-to-peak amplitude of a MEP is considered to quantify CSE, with the measured MEPs the CoG is calculated,, which is the main outcome measure of this study. A stimulation intensity of 130% RMT will be employed to obtain this outcome measure. When RMT is not enough to evoke a MEP, RMT will be aksed by letting the subject lean to the back. CSR of the lower back and abdominal muscles will be determined by measuring the cross sectional area of the hotspot leading to MEP*s in the lower back and abdominal muscles.

Secondary

MeasureTime frame
Differences in CSR changes in 4-6 week time between participants that recovered from an episode and participants who did not recover, and healthy participants, determined by the MEP amplitude of the back and abdominal muscles: CoG, latency of the MEPs, discrete peaks and map volume; the sum of the mean normalize MEP peak-to-peak amplitude. The latency, the discrete peaks and the map volume of the MEPs are used as parameters to measure CSR. Furthermore Cchanges in CSR afterwill be measured in 4-6 week time will beand tested for correlation to perceived recovery of all subjects measured on a 7 point likert scale from completely recovered to absolute worse. In addition, Ffive clinical motor and sensory control tests of the lower back will be performed. Leading to the following parameters: - Good/ false sense of graphaesthesia (refined tactile information) - Qualitative Sensory Testing (refined tactile information) - Good/ false sense of two point discrimination (refined tactile information) - Accurate precision of a motor performance task of the lower back (following a spiral on the computer screen) - Accurate/ not accurate repositioning of the lower back with eyes closed General Perceived Effect (GPE) scored on a 7 point likert scale from fully recovered to absolute worse. Pain intensity, duration of complaints of the current episode of LBP and number of recurrent LBP periodes experienced will be measured using a questionnaire at the first measurement. Furthermore the neuronavigation software records the stimulation position at the cortex and the corresponding orientation of the coil at the moment of stimulation. These measures can be used to monitor a constant stimulation position and orientation The usual care that the patients will receive, will be observed and reported.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)