NCT07059702

Brief Summary

Persons with cerebral palsy (CP) commonly suffer from fatigue. Fatigue is an important cause of their reduced participation in work or social life. Traditionally, CP-related fatigue has been viewed as related to the person's motor impairment. This view causes habilitation efforts to focus on muscle function. We hypothesize that the feeling of being fatigued must involve the activity of a specific, but un-identified, brain network that represents this particular sensation. We will use electroencephalography (EEG) and 18F-2-fluoro-2-deoxyglucose positron emission tomography (FDG-PET) in CP patients with fatigue of different degrees to identify difference in brain activity that can highlight the presumed 'fatigue network' in the brain. In this work, we build on experience from another study on fatigue in people that have had a brain abscess (see: Cognitive function and fatigue after brain abscess, NCT#: NCT04938362) Clarification of whether fatigue in CP has a muscular or cerebral cause will hopefully inform and improve habilitation efforts for this group, and it may single out fatigue as a separate treatment target.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
118mo left

Started Jul 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jul 2025Dec 2035

First Submitted

Initial submission to the registry

July 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

December 19, 2025

Status Verified

July 1, 2025

Enrollment Period

10.5 years

First QC Date

July 1, 2025

Last Update Submit

December 14, 2025

Conditions

Keywords

Fatigue in cerebral palsy

Outcome Measures

Primary Outcomes (2)

  • EEG band power

    We will analyze EEG with respect to band power within alpha, theta, and delta frequencies. We will compare EEG results from those with mild (or absent) fatigue (a 'caseness' value of 6 or less according to Chalder's fatigue questionnaire) to those with more severe fatigue (a 'caseness' value \> 6). We will compare EEG results from those with left-sided CP to those with right-sided CP and include those with symmetric CP (diplegic or tetraplegic CP) as reference.

    From enrollment to performance of EEG at 12 weeks

  • EEG band power in alpha, theta, and delta frequencies

    FDG-PET will be analyzed with respect to regional brain activity as can be inferred from the FDG-PET signal intensity. We will compare FDG-PET results from those with mild/absent fatigue to those with more severe fatigue. We will compare FDG-PET results from those with right-sided hemiplegia to those with left-sided hemiplegia and to those with di-/tetraplegia.

    From enrollment to the performance of FDG-PET: 3 months

Study Arms (1)

Persons with cerebral palsy

Persons with cerebral palsy of any degree, having fatigue of any degree.

Other: There will be no intervention.

Interventions

There will be no intervention. This is an observational study that uses EEG and FDG-PET results as parameters. These investigations will b e performed on a clinical basis.

Persons with cerebral palsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Persons with cerebral palsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurohabilitation, Oslo, Norway

Oslo, 0450, Norway

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 1, 2025

First Posted

July 11, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2035

Last Updated

December 19, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

We do not have ethical approval to share individual data with other researchers.

Locations