The objective of this study is twofold.One aim of the study is to investigate the effects of tDCS (anodal, cathodal and sham) on balance correcting responses and simple reaction times in lower extremity muscles. We will determine whether the effects…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Influence of tDCS (anodal, cathodal and sham) and group differences on:
- muscle onsets of the primovers measured by EMG in lower extremity movements
- quality of balance responses (leg angle of the step leg)
Influence on the effect of tDCS by:
- MRI based measures (DTI) of structural integrity of the corticoreticular
pathway and the corticospinal tract
Secondary outcome
- Influence of tDCS (anodal, cathodal and sham) on muscle amplitudes of the
prime movers measured by EMG in lower extremity movements
- Relation between the effecs of tDCS and functional (step onset) and clinical
outcomes
- Other MRI related outcomes, as functional connectivity in relation to the
effects of tDCS on the lower extremity movments
Background summary
In people after stroke, responses to external perturbations are delayed, which
is a main risk factor for falling. In the last decades, transcranial direct
current stimulation (tDCS) has been shown to facilitate executed movements in
stroke survivors. However, this has almost exclusively been studied in upper
extremity movements. In young adults, tDCS has recently been shown to
facilitate balance recovery responses in the lower extremities as well. This
study will investigate to what extent the latter results also apply to people
after stroke. In this population, a wide variability in effects of tDCS is
reported for upper extremity movements, which is expected to be due to the
amount of cortical integrity after the CVA. Therefore, this study will also
investigate the relation between the effects of two types of stimulation
(anodal over the affected hemisphere, and cathodal over the unaffected
hemisphere) and MRI obtained values for cortical integrity of the motor
regions.
Study objective
The objective of this study is twofold.
One aim of the study is to investigate the effects of tDCS (anodal, cathodal
and sham) on balance correcting responses and simple reaction times in lower
extremity muscles. We will determine whether the effects of tDCS are different
between people after stroke and healthy controls (within similar age range and
in young controls).
Another goal is to investigate whether neuroimaging based measures of integrity
of neural motor pathways can explain the anticipated variability of
tDCS-induced effects in people after stroke.
Study design
randomized single-blind sham-controlled cross-over study
Study burden and risks
Participants will not directly benefit from their participation in the study.
MRI scans are painless and safe. MRI is a technique without radiation (unlike
x-ray and CT scans). In case of unexpected findings, the participant will be
informed by his physician. Transcranial direct current stimulation (tDCS) is a
widely used non-invasive brain stimulation technique, applying weak direct
currents via conductive sponge electrodes to the scalp. These weak currents can
slightly shift the neurons* membrane potential and thereby increase or decrease
spontaneous neuronal activity in the stimulated cortex, but (unlike TMS) they
do not evoke action potentials. During the stimulation, participants may
transiently experience light tingling, itching or burning sensations on the
skin underlying the electrodes, which can be unpleasant. The most common side
effects are a light transient headache and a feeling of fatigue. In the current
study, participants will be stimulated with a protocol that is considered safe
with respect to the latest published safety guidelines. All subjects are
screened for their relevant medical history and other tDCS safety aspects (e.g.
metal parts in the head, skin allergies). Postural responses will be assessed
on the Radboud Falls Simulator. Participants will be exposed to balance
perturbations by sudden translations of the support surface. There are no risks
of participating in the balance assessment, since rails are mounted around the
balance platform and participants wear a safety harness. From previous studies
at our department, we know that people (after a CVA) should be able to overcome
the balance perturbations at the proposed intensity. In summary, because the
risk is negligible and the burden associated with participation can be
considered minimal, we do not expect serious adverse events due to the project.
Reinier Postlaan 2
Nijmegen 6525 GC
NL
Reinier Postlaan 2
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
Only people over 18 years old in the chronic phase after experiencing a supratentorial unilateral stroke (> 6 months in the past) that resulted in hemi pareses will be recruited for this study. Furthermore, healthy controls of similar age and with a similar male:female ratio will be enrolled in the study and 10 healthy young controls (18 - 30 year) are included for the tDCS sessions only.
Exclusion criteria
• Serious head trauma or head, neck or shoulder surgery in the past
• Large or ferromagnetic metal parts in the upper body (except for dental fillings and wire)
• Implanted cardiac pacemaker or neurostimulator (too close to the head) or Venous Access Port
• Pregnancy
• Skin diseases at intended electrode sites (tDCS or EMG electrodes)
• Any prescribed medication that can alter cortical excitability (e.g. anti epileptics, tricyclic anti-depressives or benzodiazepines) within two weeks prior to participation.
• Participated in a TMS or tCS study less than 1 year ago.
• Suffering from claustrophobia
• Suffering from epilepsy
• Irremovable piercing or medical patch
• Any neurological or orthopaedic disorder (other than stroke) that may interfere with the MRI outcomes of interest and/or with the performance on the movement tasks
• Disorders of hearing, which cannot be corrected to normal.
• Medication negatively affecting balance or reaction times (e.g. neuroleptics, antidepressants, anticonvulsants, sedatives)
• Severe cognitive impairment (mini mental state examination (MMSE) <24)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL51735.091.15 |
OMON | NL-OMON20568 |
OMON | NL-OMON24501 |