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Auricular vagal nerve stimulation combined with rehabilitation to enhance functional outcome in cerebral palsy patients with upper extremity deficits (AVANS study) Part1

Auricular vagal nerve stimulation combined with rehabilitation to enhance functional outcome in cerebral palsy patients with upper extremity deficits (AVANS study) Part1 - AVANS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57283
Enrollment
36
Registered
2025-02-03
Start date
2024-10-01
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

cerebral palsy spasticity

Interventions

It is unknown which aVNS stimulation intensity is the most effective in inducing cortical plasticity and improving the performance of a simple motor task. Therefore, the group will be divided into t

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Healthy subjects aged 18-70 years Proficient in Dutch language Sufficient cognitive function to follow instructions

Exclusion criteria

Exclusion criteria: History of stroke/ epilepsy or other neurological impairments Functional impairments/ pain/ sensory deficits of hand/arm. Previous injury or intervention of the vagal nerve Persons with cardiac diseases

Design outcomes

Primary

MeasureTime frame
Motor Evoked Potential (MEP) parameters will be assessed before and after the task to measure changes in cortical plasticity.

Secondary

MeasureTime frame
The secondary outcome parameters are the difference in motor performance during the stacking test and the difference in somatosensory evoked potential (SSEP), different stimulation intensities will be tested.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)