Cerebral Activation and Apprehension in Patients With Shoulder Instability.

NCT06157788 | Completed

• 1 other identifier: 2022-00135
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

In a similar study, the investigators demonstrated that shoulder stabilization could allow the brain to partially "recover". Patients with shoulder apprehension underwent clinical and fMRI examination before and one year after shoulder stabilization surgery. Clinical examination showed a significant improvement in postoperative shoulder function compared with preoperative. Coherently, results showed a decreased activation in the left pre-motor cortex postoperatively, demonstrating that stabilization surgery induced improvements both at the physical and at the brain levels, one year postoperatively. Most interestingly, right-frontal pole and right-occipital cortex activity was associated with good outcome in shoulder performance.

Conditions

Shoulder Instability

Outcome Measures

Primary Outcomes (1)

• Task-related brain activation

  Temporal independent component analysis of functional Connectivity

  At 10 post-operative years

Secondary Outcomes (9)

• Behavioural responses to apprehension videos

  At 10 post-operative years

• Changes in grey matter

  At 10 post-operative years

• Changes in white matter

  At 10 post-operative years

• Pain on visual analog scale

  At 10 post-operative years

• Subjective Shoulder Value

  At 10 post-operative years

Study Arms (2)

Operated group

Patients were male individuals with anterior glenohumeral instability, who underwent preoperative fMRI, then surgical stabilization by 2 specialized shoulder surgeons, followed by a new fMRI one year postoperatively.

Diagnostic Test: functional Magnetic Resonance Imaging and clinical assessment

Control Group

The control group consisted in healthy volunteers with no history of shoulder injury, instability, or hyperlaxity, the latter defined as more than 85° of external rotation elbow against waist, or hyperabduction over 105°, who had undergone fMRI at baseline.

Diagnostic Test: functional Magnetic Resonance Imaging and clinical assessment

Interventions

functional Magnetic Resonance Imaging and clinical assessment DIAGNOSTIC_TEST

* fMRI task: In the active condition, video cues were utilized (lasting 10s) depicting everyday activities that trigger shoulder apprehension. Control videos were created to match the previous content, except for the absence of cues inducing shoulder apprehension. Following each video, a visual analog scale appeared for a duration of 2.5s, and participant were asked to rate the level of perceived apprehension, using an MRI-compatible response box. The rating scale consisted of nine steps, ranging from no apprehension to high apprehension. After providing their rating, participants had a rest period during which a fixation cross was displayed visually for 17.5s. Apprehension and control videos were shown in a pseudo-randomized fashion. * General Linear Model Analysis of Task-Related Activation * TICA Analysis of Functional Connectivity * White Matter TBSS of DTI Data * Voxel-based morphometry analysis of T1 images

Control Group; Operated group

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were male individuals with anterior glenohumeral instability, who underwent preoperative fMRI, then surgical stabilization by 2 specialized shoulder surgeons, followed by a new fMRI one year postoperatively. The control group consisted in healthy volunteers with no history of shoulder injury, instability, or hyperlaxity, the latter defined as more than 85° of external rotation elbow against waist, or hyperabduction over 105°, who had undergone fMRI at baseline.

You may qualify if:

• The 15 patients operated 10 years ago and the 15 patients used as a control group in a previous analysis.

You may not qualify if:

• Previous recurrence of instability reported in the past 10 years.
• Major medical disorders (cancer, cardiac illness)
• Sustained head injury
• Psychiatric or neurologic disorders
• Alcohol or drug abuse
• Use of psychotropics, stimulants, and beta-blockers on a regular basis
• Abnormal or non-corrected-to-normal visual acuity
• New contra-indication for fMRI, such as claustrophobia, pacemaker

Sponsors & Collaborators

• La Tour Hospital: lead

Study Sites (1)

La Tour hospital

Meyrin, Canton of Geneva, 1217, Switzerland

Location

Related Publications (1)

• Haller S, Cunningham G, Laedermann A, Hofmeister J, Van De Ville D, Lovblad KO, Hoffmeyer P. Shoulder apprehension impacts large-scale functional brain networks. AJNR Am J Neuroradiol. 2014 Apr;35(4):691-7. doi: 10.3174/ajnr.A3738. Epub 2013 Oct 3.

  PMID: 24091445 BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 6, 2023
• Study Start: April 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

CH (1)