The primary objective of this pilot study is therefore to investigate the effects of TENS on brain activity in pwMS measured with fMRI.
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Blood-oxygen-level-dependent (BOLD) activation changes and the interaction
networks before, during and after active TENS and differences in activation due
to active stimulation vs. sham stimulation and active stimulation on tibialis
anterior vs active stimulation combined with plantar/dorsiflexion.
Secondary outcome
Changes in brain activity and the interaction networks focussing on the
thalamus (integration station of sensory input), sensory cortex (sensory
awareness) and motor cortices (sensorimotor integration) before, during and
after active stimulation of the quadriceps femoris vs. tibialis anterior,
active stimulation of the tibialis anterior vs. plantar/dorsiflexion, sham
stimulation of the tibialis anterior vs. sham stimulation combined with
plantar/dorsiflexion and active stimulation in pwMS vs. active stimulation in
controls.
Background summary
Transcutaneous Electrical Nerve Stimulation (TENS) is a new treatment that
could potentially reduce walking problems and fatigue in persons with Multiple
Sclerosis. However, extensive use of TENS in a clinical setting is hindered by
a lack of neurophysiological understanding of the effects of TENS.
Study objective
The primary objective of this pilot study is therefore to investigate the
effects of TENS on brain activity in pwMS measured with fMRI.
Study design
This study is a pilot study to see if we can detect changes in fMRI activity
during TENS in persons with MS. This is a randomized, single-blind crossover
design. Subjects will undergo an MRI scan while they receive sham stimulation
of the tibialis anterior, active stimulation of the tibialis anterior,
stimulation of the quadriceps, perform continuous movements of the foot
(plantar & dorsiflexion) and a combination of stimulation of the tibialis
anterior and movement of the foot.
Intervention
Active or sham TENS either in rest or in combination with foot movements.
Study burden and risks
There are no serious risks involved in the measurements nor the TENS protocol.
The time investment for the subject is 1 appointment of a total 3 hours.
fMRI measurements are non-invasive and non-painful. The only known risks are to
individuals with cardiac pacemakers, certain types of metallic implants, and
metal splinter in the eyes. Subjects will have to fill out a safety
questionnaire to make sure they are not at risk. The neurophysiological effects
of TENS are not known. This study can add to the limited knowledge and possibly
help to personalize and implement TENS in the clinic.
Hanzeplein 1
Groningen 9700AV
NL
Hanzeplein 1
Groningen 9700AV
NL
Listed location countries
Age
Inclusion criteria
- age: 18-65 years
- EDSS score < 7
Exclusion criteria
- metal or electrical implants
- BMI > 40
- claustrophobia
- being pregnant
- having a psychiatric disorder
- having cognitive or communication problems which reduces the capacity to
understand instructions
- having a neurological disorder other than MS
- having cardiac arrhythmia
- having a pacemaker or another implantable electronic apparatus.
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 | NL86181.042.24 |