## Protocol Section
### Identification Module
**NCT ID:** NCT06413667

**Acronym:** MRAtlas

**Brief Title:** Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder

**Official Title:** Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder

#### Organization Study ID Info
**ID:** 2023.0628
#### Organization
**Class:** OTHER
**Full Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
### Status Module
#### Completion Date
**Date:** 2026-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-08

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-15
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

#### Responsible Party

**Investigator Affiliation:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

**Investigator Full Name:** Aart Nederveen

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Whiplash is an injury caused by the rapid forward and backward movement of the neck, leading to injuries in bones or soft tissues, along with various symptoms. Recent studies indicate that muscles affected by whiplash may show increased fat buildup and reduced muscle volume. However, these changes in muscle do not completely account for the pain and other symptoms reported. Besides soft tissues, whiplash can also injure bone structures, including the cervical spine. Until now, studies focused mainly on fractures of the cervical spine, often overlooking the position and alignment of the atlas and dens (C1 and C2). The aim of this study is to evaluate the position and alignment of the Atlas in chronic whiplash-associated disorder (grades 1 or 2) and compare it to patients with tension headache and healthy controls. Additionally, it will explore how these factors relate to pain intensity, neck movement limitations, daily activities, overall improvement, and quality of life.

**Detailed Description:** Treating some neurological conditions, like chronic whiplash-associated disorder (WAD), is highly challenging for medical practitioners. Patients with chronic WAD frequently visit their general practitioner because it's hard to pinpoint the cause of their symptoms. This makes finding the right treatment very difficult. The number of chronic WAD cases is rising worldwide, costing Europe an estimated 10 billion euros annually. Half of all whiplash injuries develop into chronic conditions, leading to significant disability and societal costs. These patients face major limitations in daily activities, greatly affecting their quality of life.

Whiplash is an injury caused by the rapid forward and backward movement of the neck, leading to injuries in bones or soft tissues, along with various symptoms. Recent studies indicate that muscles affected by whiplash may show increased fat buildup and reduced muscle volume. However, these changes in muscle do not completely account for the pain and other symptoms reported. Besides soft tissues, whiplash can also injure bone structures, including the cervical spine. Until now, studies focused mainly on fractures of the cervical spine, often overlooking the position and alignment of the atlas and dens (C1 and C2).

The aim of this study is to apply advanced imaging technologies to assess the position and alignment of the Atlas (C1) and the surrounding tissues. The study has three main goals:

i. Study the feasibility and repeatability of state-of-the-art MRI measurements in 30 healthy controls across an age range of 18 to 75 years.

ii. Assess the position and alignment of the Atlas and surrounding tissues using MRI in patients with WAD, compared to patients with tension headaches and healthy control participants;

iii. Relate these MRI parameters to neurological examinations and questionnaires (patient- reported outcome measures) in patients with WAD and tension headaches.

### Conditions Module

**Conditions:**

- Chronic Whiplash Associated Disorder

**Keywords:**

- Atlas

- MRI

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Healthy control participants without intervention

**Label:** Control participants

#### Arm Group 2

**Description:** Chronic Whiplash Associated Disorder without intervention

**Label:** Chronic Whiplash Associated Disorder

#### Arm Group 3

**Description:** Tension headache without intervention

**Label:** Tension headache

### Outcomes Module

#### Primary Outcomes

**Description:** MRI images will be used to measure the angles between the Atlas and adjacent vertebrae at two different time points in the same healthy participants.

**Measure:** Repeatability measurement

**Time Frame:** 12 months

**Description:** MRI images will be used to measure the angles between the Atlas and adjacent vertebrae in the patient groups.

**Measure:** Alignment of the Atlas

**Time Frame:** 12 months

**Description:** A neurological examination will be performed and scored during the participants' visit

**Measure:** Neurological examination scores

**Time Frame:** 18 months

**Description:** The scores will be obtained by using quality of life questionnaire

**Measure:** Quality of life scores

**Time Frame:** 18 months

#### Secondary Outcomes

**Description:** Muscle volume (in mm3) will be measured from the quantitative MRI scans and compared across the groups.

**Measure:** Muscle volume

**Time Frame:** 24 months

**Description:** Fat fraction (in %) will be measured from MRI and compared across the groups.

**Measure:** Fat fraction

**Time Frame:** 24 months

**Description:** Blood flow (in cm/s) in the brain feeding arteries will be obtained from the quantitative MRI scans and compared across the groups.

**Measure:** Blood flow

**Time Frame:** 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria: Participants fulfilling the criteria mentioned below:

Control participants In order to be eligible to participate in this study, a participant must meet the following criteria:

* Healthy individuals
* Ability to follow test instructions
* Aged between 18 - 75 years

Chronic Whiplash Associated Disorder

In order to be eligible to participate in this study, a participant must meet the following criteria:

* Healthy individuals
* Ability to follow test instructions
* WAD 1 or 2 Diagnosis
* Aged between 18 - 75 years

Tension headache

In order to be eligible to participate in this study, a participant must meet the following criteria:

* Healthy individuals
* Ability to follow test instructions
* Diagnosis Tension headache
* Aged between 18 -75 years

Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Inability to provide informed consent
* Have a history of claustrophobia
* Patient/ participant is not eligible to follow instructions
* Contra-indication for MRI (e.g., pacemaker, claustrophobia)
* Being under investigation for non-diagnosed disease at the time of investigation

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The aim of this study is to evaluate high resolution MR techniques to measure position and alignment of the Atlas and its surrounding structures in healthy participants, individuals with tension headache and individuals with chronic whiplash disorder.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** a.j.nederveen@amsterdamumc.nl

**Name:** Nederveen

**Phone:** +31 20 5629338

**Role:** CONTACT

**Contact 2:**

**Email:** l.afzali-hashemi@amsterdamumc.nl

**Name:** Afzali-Hashemi

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Amsterdam

**Contacts:**

***Contact 1:***

- **Email:** a.j.nederveen@amsterdamumc.nl

- **Name:** Nederveen

- **Role:** CONTACT

**Country:** Netherlands

**Facility:** Amsterdam UMC

**Status:** RECRUITING

**Zip:** 1105 AZ

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019838

- Term: Neck Injuries

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17651

- Name: Whiplash Injuries

- Relevance: HIGH

- As Found: Whiplash

- ID: M21725

- Name: Neck Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014911

- Term: Whiplash Injuries

### Misc Info Module

- Version Holder: 2024-05-31
