Electromyography to assess the change in muscle activity as a result of intrathecal baclofen treatment

Electromyography to assess the change in muscle activity as a result of intrathecal baclofen treatment - EMG in ITB

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53254

Enrollment

Registered

2023-10-20

Start date

2023-11-13

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

spasticity

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Receiving an intrathecal baclofen trial (single shot baclofen test or external intrathecal baclofen pump implantation) or permanent intrathecal baclofen pump implantation • Unilateral or bilateral spasticity of lower limbs • Modified Ashworth Scale and electromyography measurements possible (18,5 * BMI

Exclusion criteria

Exclusion criteria: • Age under 18 years old • High sensitivity of lower limb skin

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the change in muscle activity measured by EMG. The change in muscle activity is assessed by analysis of the amplitude, the root mean square, the power spectral density and the co-contraction index of the EMG signals. The EMG signals are measured during rest, during the MAS assessment and during voluntary contraction by the participant.	—

Secondary

Measure	Time frame
Secondary study parameters are the MAS indices of the participants before and after ITB treatment and the Patient Global Impression of Change reported by the participants, and the correlation between de EMG features and MAS and PGIC.	—

Countries

Netherlands

Outcome results