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Completed

NCT Number: NCT03441009

Metabolism and the Activity of the Autonomic Nervous System in Patients With Paroxystic Sympathetic Hyperactivity, PSH

Adult patients suffering from acquired brain damage run the risk of developing PSH. This group of patients is admitted to our unit, the Neurointensive Stepdown Unit, at Silkeborg Regional Hospital for intensive care and early neurorehabilitation. After weaning from intensive carethey are transferred to Hammel NeuroCentre.

Aim is to assess whether HRV-derived variables in the frequency domain mirror therapeutic and/or nursing and/or pharmacologic interventions. To the extent clinically available BRS and metabolism are included in the assessment.

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Key information

Conditions

Autonomic Nervous System Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

See report:

Honore H, Eggertsen K, Sondergaard S: A study into the feasibility of using HRV variables to guide treatment in patients with paroxystic sympathetic hyperactivity in a neurointensive step-down unit. NeuroRehabilitation 2019, 44(1):141-155.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Symptoms of PSH according to Baguley scoring table

Exclusion criteria

No symptoms of PSH

Treatment and study plan

Physio-/occupational therapy

Other

Physio-/occupational therapy, ADL

Other names: Psycotropic medications

Primary outcomes

  1. Difference before vs after intervention in frequency domain parameters of HRV

    Time frame: immediate

    HRV parameters: low frequency (LF, 0.04-0.15 Hz), high frequency (HF, 0.15-0.4 Hz) in terms of peak frequency (Hz), absolute power (ms2, natural logarithm transformed values of absolute powers of VLF, LF, and HF bands), relative power (absolute power/total power), normalized power (%, normalized units, n.u.), total power given by VLF + HF + LF (ms2) and LF/HF ratio.

  2. Qualitative description expressed as goal attainment scaling (GAS) of therapeutic interventions

    Time frame: immediate

    Two independent ratings on a 5-point scale, -2 to +2

Sponsors and collaborators

Lead sponsor

Region MidtJylland Denmark

Other

Registry information

Acronym: MANS-PSH

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 22, 2018
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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