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

September 18, 2021 updated by: Soren Sondergaard, Region MidtJylland Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

15

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to NISU from tertiary health care facilities for intensive care in combination with early neurorehabilitation

Description

Inclusion Criteria:

Symptoms of PSH according to Baguley scoring table

Exclusion Criteria:

No symptoms of PSH

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
immediate
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
immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region MidtJylland Denmark

Investigators

  • Study Chair: Jørgen Feldbæk, Professor, Hammel Neuro- and Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2016

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 18, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 654865

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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