NCT07425613

Brief Summary

Degenerative cervical disc disease can cause neck pain, nerve symptoms, dizziness, and problems with balance and head movement control. The neck contains many sensory receptors that provide information about head position and movement to the brain. When cervical discs degenerate or compress nearby structures, this sensory communication may be disrupted. As a result, patients may experience reduced accuracy and coordination of head movements. Anterior cervical discectomy and fusion (ACDF) is a standard surgical procedure used to relieve nerve or spinal cord compression caused by cervical disc disease. The procedure is effective in reducing pain and neurological symptoms. However, it is not well understood whether ACDF also improves the way the neck and nervous system work together to control head movement. The purpose of this study is to evaluate early changes in cervical movement control after ACDF. Patients scheduled for ACDF will be assessed before surgery and again one week after surgery. A group of healthy participants without neck pain will be assessed at the same time interval for comparison. Cervical movement control will be measured using a computer-based head-tracking task. During this task, participants follow a moving target on a screen using controlled head movements. The system records measures of tracking accuracy and timing. The primary research question is whether ACDF results in measurable short-term improvements in objective cervical movement control compared with healthy individuals over the same time period. It is hypothesized that patients undergoing ACDF will demonstrate improvement in specific movement-control measures after surgery. However, broader patterns of movement-control impairment may not fully normalize in the early postoperative period. The results of this study may improve understanding of how cervical spine surgery affects sensorimotor function and may help inform postoperative rehabilitation strategies.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

February 13, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

24 days

First QC Date

February 13, 2026

Last Update Submit

February 13, 2026

Conditions

Keywords

Anterior Cervical Discectomy and FusionCervical Sensorimotor ControlCervicocephalic KinaesthesiaHead and neck movement control testPostoperative RecoveryCervical Spine SurgeryMovement ControlNeck Proprioception

Outcome Measures

Primary Outcomes (4)

  • Change From Baseline in Time-on-Target at Medium Difficulty During Dynamic Cervical Head Tracking at 1 Week

    Time-on-target is defined as the percentage of total trial time during which the head-controlled cursor remains within a predefined target zone while following an unpredictably moving visual target on a computer screen. Head motion is recorded using a head-mounted inertial measurement unit during a standardized dynamic tracking task. The medium difficulty level involves predefined target speed and trajectory complexity. Values range from 0% to 100%, with higher percentages indicating better tracking accuracy and movement control. Change from baseline to one week postoperatively will be calculated for analysis.

    Baseline (within 1 week prior to surgery) and 1 week after surgery

  • Change From Baseline in Amplitude Accuracy During Dynamic Cervical Head Tracking at 1 Week

    Amplitude accuracy is defined as the mean spatial deviation, expressed in millimeters (mm), between a moving visual target and the head-controlled cursor during a standardized dynamic head-tracking task. Head motion is recorded using a head-mounted inertial measurement unit. Values are continuous and expressed in millimeters, with lower values indicating better tracking precision and movement control. Change from baseline to one week postoperatively will be calculated for analysis.

    Baseline (within 1 week prior to surgery) and 1 week after surgery

  • Change From Baseline in Undershoot During Dynamic Cervical Head Tracking at 1 Week

    Undershoot is defined as the percentage of total trial time during which the head-controlled cursor remains behind the moving visual target while performing a standardized dynamic head-tracking task. Head motion is recorded using a head-mounted inertial measurement unit. Values range from 0% to 100%, with lower percentages indicating better tracking performance and improved temporal control. Change from baseline to one week postoperatively will be calculated for analysis.

    Baseline (within 1 week prior to surgery) and 1 week after surgery

  • Change From Baseline in Overshoot During Dynamic Cervical Head Tracking at 1 Week

    Overshoot is defined as the percentage of total trial time during which the head-controlled cursor moves ahead of the moving visual target during a standardized dynamic head-tracking task. Head motion is recorded using a head-mounted inertial measurement unit. Values range from 0% to 100%, with lower percentages indicating better tracking precision and movement regulation. Change from baseline to one week postoperatively will be calculated for analysis.

    Baseline (within 1 week prior to surgery) and 1 week after surgery

Secondary Outcomes (1)

  • Change From Baseline in Movement-Control Impairment Cluster Classification at 1 Week

    Baseline (within 1 week prior to surgery) and 1 week after surgery

Study Arms (2)

Anterior Cervical Discectomy and Fusion (ACDF)

EXPERIMENTAL

Participants diagnosed with cervical disc pathology and scheduled to undergo anterior cervical discectomy and fusion (ACDF) as part of standard clinical care. Cervical movement control will be assessed within one week prior to surgery and again one week after surgery using a standardized dynamic head-tracking task. Changes in movement-control parameters will be analyzed to evaluate early postoperative sensorimotor changes.

Procedure: Anterior Cervical Discectomy and Fusion

Non-Surgical Neck Pain Group

NO INTERVENTION

Participants diagnosed with neck pain who are not undergoing surgical treatment will serve as the comparison group. These participants will be assessed at two time points separated by a comparable interval to the surgical group. Cervical movement control will be evaluated using the same standardized dynamic head-tracking task. No surgical intervention will be performed during the study period.

Interventions

Anterior cervical discectomy and fusion (ACDF) is a surgical procedure performed under general anesthesia to treat cervical disc herniation or degenerative disc disease causing nerve root or spinal cord compression. The procedure involves an anterior approach to the cervical spine, removal of the affected intervertebral disc (discectomy), decompression of neural structures, and placement of an interbody graft or cage with or without anterior plate fixation to achieve segmental fusion. The specific surgical technique and implant selection are determined by the treating spine surgeon according to standard clinical practice.

Anterior Cervical Discectomy and Fusion (ACDF)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Surgical group:
  • Age 18 to 65 years
  • Clinical diagnosis of cervical disc pathology at one segment level (e.g., cervical disc herniation or degenerative disc disease)
  • Scheduled to undergo anterior cervical discectomy and fusion (ACDF) as part of standard clinical care
  • Ability to understand study procedures and provide written informed consent
  • Non-Surgical neck pain group:
  • Age 18 to 65 years
  • Clinical diagnosis of neck pain associated with cervical disc pathology
  • Not undergoing surgical treatment during the study period
  • Ability to understand study procedures and provide written informed consent

You may not qualify if:

  • Prior cervical spine surgery
  • Diagnosed neurological disorders unrelated to cervical disc pathology (e.g., multiple sclerosis, Parkinson's disease, stroke)
  • Known vestibular disorders affecting balance
  • Severe uncorrected visual impairment
  • Acute musculoskeletal injury of the neck or upper limb unrelated to the primary cervical condition
  • Inability to perform the head-tracking task
  • Cognitive impairment preventing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sport, University of Ljubljana

Ljubljana, 3000, Slovenia

RECRUITING

Related Publications (16)

  • Zheng, H.-L., et al. (2022). ACDF to treat cervical instability with vertigo and dizziness. Frontiers in Surgery, 9, 1047504.

    BACKGROUND
  • Yang, L., et al. (2017). Mechanoreceptors in diseased cervical intervertebral disc and vertigo. Spine, 42(8), 540-546.

    BACKGROUND
  • Wrisley, D. M., et al. (2000). Cervicogenic dizziness: A review of diagnosis and treatment. J Orthop Sports Phys Ther, 30(12), 755-766.*

    BACKGROUND
  • Treleaven, J. (2008). Sensorimotor disturbances in neck disorders-Part 2. Manual Therapy, 13(3), 266-275.

    BACKGROUND
  • Takayama, H., et al. (2005). Proprioceptive recovery of patients with cervical myelopathy after surgical decompression. Spine, 30(9), 1039-1044.

    BACKGROUND
  • Peng, B. (2018). Cervical vertigo: Historical reviews and advances. World Neurosurgery, 109, 347-350.

    BACKGROUND
  • Mendel, T., Wink, C. S., & Zimny, M. L. (1992). Neural elements in human cervical intervertebral discs. Spine, 17(2), 132-135.

    BACKGROUND
  • Majcen Rosker, Z., Vodicar, M., & Kristjansson, E. (2022). Altered oculomotor control during smooth pursuit neck torsion test. Int J Environ Res Public Health, 19(7).*

    BACKGROUND
  • Majcen Rosker, Z., & Rosker, J. (2024). Cervicocephalic kinaesthesia reveals novel subgroups of motor control impairments in patients with neck pain. Scientific Reports, 14, 8383.

    BACKGROUND
  • Majcen Rosker, Z., Kristjansson, E., & Vodicar, M. (2023). Detection of cervical-driven sensorimotor dysfunction in concussion patients. Gait & Posture, 101, 21-27.

    BACKGROUND
  • Magnusson, M., & Malmström, E.-M. (2016). The conundrum of cervicogenic dizziness. Handbook of Clinical Neurology, 137, 365-369.

    BACKGROUND
  • Liu, T.-H., Liu, Y.-Q., & Peng, B.-G. (2021). Cervical intervertebral disc degeneration and dizziness. World Journal of Clinical Cases, 9(9), 2146-2152.*

    BACKGROUND
  • Kristjansson, E., & Treleaven, J. (2009). Sensorimotor function and dizziness in neck pain: Implications for assessment and management. J Orthop Sports Phys Ther, 39(5).

    BACKGROUND
  • Cloward, R. B. (1958). The anterior approach for removal of ruptured cervical disks. Journal of Neurosurgery, 15(6). PMID: 13585189

    BACKGROUND
  • Boyd-Clark, L. C., Briggs, C. A., & Galea, M. P. (2002). Muscle spindle distribution, morphology, and density in longus colli and multifidus muscles of the cervical spine. Spine, 27(7), 694-701. PMID: 11923660

    BACKGROUND
  • Bogduk, N., & Govind, J. (2009). Cervicogenic headache: An assessment of the evidence on clinical diagnosis, invasive tests, and treatment. The Lancet Neurology, 8(10), 959-968.

    BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Recombination, GeneticGenetic Phenomena

Study Officials

  • Ziva Majcen Rosker, PhD

    Faculty of Sport, University of Ljubljana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziva dr. Majcen Rosker, PhD

CONTACT

Miha dr. Vodicar, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study uses a non-randomized parallel assignment design. Participants undergoing anterior cervical discectomy and fusion (ACDF) for cervical disc pathology are assigned to the surgical group and assessed at two time points: preoperatively and one week postoperatively. A matched comparison group of patients with neck pain who are not undergoing surgical treatment is assessed at two time points separated by a comparable interval without receiving surgery. The study compares changes in cervical movement-control measures between the surgical and non-surgical groups over the same time period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Kinesiology, Faculty of Sport, University of Ljubljana

Study Record Dates

First Submitted

February 13, 2026

First Posted

February 23, 2026

Study Start

February 20, 2026

Primary Completion

March 16, 2026

Study Completion

March 30, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data collected in this study will not be made publicly available. The sample size is relatively small and includes patients treated at a single clinical center, which may increase the risk of indirect participant identification despite de-identification procedures. Additionally, the dataset includes detailed movement-control performance variables and clinical characteristics that could potentially allow re-identification when combined with other publicly available information. Data were collected under informed consent and ethics approval that did not include provisions for public sharing of individual-level data. Aggregate results will be reported in scientific publications to ensure transparency while maintaining participant confidentiality.

Locations