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CompletedNCT06157788Updated Dec 14, 2023

Cerebral Activation and Apprehension in Patients With Shoulder Instability.

An observational study in Shoulder Instability, sponsored by La Tour Hospital. Completed at 1 site in Switzerland. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-14.

Sponsored by La Tour Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
19
Sex
Male
01

Study 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.

Read the detailed description

Fear, anxiety and anticipation of situations that could lead to a dislocation are essential cognitive processes in shoulder apprehension. Functional magnetic resonance imaging (fMRI) measures brain activity by detecting changes associated with blood flow. This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases. Recently, investigators used fMRI with visual apprehension stimulation to explore neuronal connections and cerebral changes induced by shoulder dislocation. Several cerebral areas were modified during those analyses, representing the different aspects of shoulder apprehension. Specific reorganizations were found in apprehension-related functional connectivity of the primary sensory-motor areas (motor resistance), dorsolateral prefrontal cortex (cognitive control of motor behavior), and the dorsal anterior cingulate cortex/dorsomedial prefrontal cortex and anterior insula (anxiety and emotional regulation).

Those regions are involved in the cognitive control of motor behavior. Hence, there is a motor control anticipation and muscular resistance (protective reflex mechanism), in order to avoid shoulder movement that could lead to dislocation. Another recent study published by Shitara et al. analyzed cerebral changes induced by shoulder dislocation in 14 patients. Although results were similar to the investigators' study, they observed a larger and less specific spectrum of activated cerebral areas, that may be explained by the fact that they projected static and abstract images during fMRI acquisition that may be prone to vaguer and subjective interpretation, and that moreover did not convey the dynamic component inherent to apprehension. In a subsequent study, investigators extended these findings by investigating further structural alterations in patients with shoulder apprehension. The investigators found that fractional anisotropy, representing white matter integrity, was increased in the left internal capsule and partially in the thalamus of studied patients compared to healthy controls. Fractional anisotropy correlated positively with pain visual analogue scale (VAS) scores (p \< .05) and negatively with simple shoulder test (SST) scores (p \< .05). This suggests an abnormal increased axonal integrity and therefore pathological structural plasticity due to the over-connection of white matter fibers in the motor pathway. These structural alterations affect several dimensions of shoulder apprehension as pain perception and performance in daily life.

The neuronal changes previously mentioned and presented in shoulder apprehension can also be assessed in daily clinical practice. Indeed, Cunningham et al. correlated clinical scores and tests (Rowe, pain VAS, SST, subjective shoulder value (SSV), WOSI) with functional cerebral imaging in patients with shoulder apprehension. Their hypothesis was that it might be possible to simplify shoulder instability scores as it has been previously possible with rotator cuff and SLAP lesions, and that at least one score could encompass the spectrum of these cerebral alterations. They found that the Rowe score integrated several aspects of apprehension, notably the motor and sensory functions, as well as pain anticipation and attention. This could be explained by the fact that the Rowe score is the only tested score that integrates range of motion. This also provides the ability to evaluate motor component (stability and motion) and cognitive component (perceived pain) of shoulder apprehension. Pain VAS and WOSI seemed to correlate with less brain networks compared to the Rowe. This could be explained by the fact that their assessment is focused only on cognitive aspects (pain for pain VAS, shoulder function in everyday life activities for WOSI), and that they do not integrate pure shoulder motion. SST and SSV were not found to be associated with brain network alterations, which is corroborated by the fact that they are general shoulder scores and were not specifically validated for instability.

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.

02

Conditions studied

  • Shoulder Instability
03

In context

Lead sponsor

La Tour Hospital is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
19 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testfunctional Magnetic Resonance Imaging and clinical assessment

    * 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

06

What researchers measure

Primary outcomes

  1. Task-related brain activation

    Temporal independent component analysis of functional Connectivity

    Time frame: At 10 post-operative years

Secondary outcomes

  1. Behavioural responses to apprehension videos

    Minimum 1 (No Apprehension), Maximum 7 (Apprehension)

    Time frame: At 10 post-operative years

  2. Changes in grey matter

    Structural changes in grey matter using voxel-based morphometry

    Time frame: At 10 post-operative years

  3. Changes in white matter

    structural changes in white matter using tract-based spatial statistics analysis with multimodal Magnetic Resonance imaging

    Time frame: At 10 post-operative years

  4. Pain on visual analog scale

    From 0 (no pain) to 10 (extreme pain)

    Time frame: At 10 post-operative years

  5. Subjective Shoulder Value

    SSV (Subjective Shoulder Value). From 0 (worst) to 100 (best)

    Time frame: At 10 post-operative years

  6. Rowe score

    From 0 (worst) to 100 (best)

    Time frame: At 10 post-operative years

  7. Simple Shoulder Test

    From 0 (worst) to 12 (best)

    Time frame: At 10 post-operative years

  8. Western Ontario Shoulder Instability Index

    From 0 (worst) to 100 (best)

    Time frame: At 10 post-operative years

  9. Single Assessment numeric evaluation score

    Single Assessment numeric evaluation (SANE). From 0 (worst) to 100 (best)

    Time frame: At 10 post-operative years

07

Study locations

1 site
  • La Tour hospital
    Meyrin, Geneva 1217, Switzerland
08

References and documents

Publications

  • 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. PubMed 24091445 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06157788
Lead sponsor
La Tour Hospital
Responsible party
Dr. Alexandre Lädermann (Orthopaedic Surgeon, La Tour Hospital) — Principal investigator
First posted
Dec 6, 2023
Start date
Apr 1, 2022
Primary completion
Oct 1, 2023
Completion
Oct 1, 2023
Last update
Dec 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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