Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction (NA-CONTROL)

March 16, 2021 updated by: Radboud University Medical Center

This study evaluates the effect of a specific, multidisciplinary and personalized rehabilitation program compared to usual care, on motor control and functional disability in patients with neuralgic amyotrophy.

Half of the participants will start with the 17-week specific rehabilitation program while the other half will first continue their usual care for 17 weeks, after which they will also receive the 17-week specific rehabilitation program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Neuralgic amyotrophy (NA) is a common (incidence 1:1000) peripheral nervous system disorder caused by acute autoimmune inflammation of the brachial plexus, the nerve bundle going to the shoulder and arm. Many NA patients develop abnormal motor control of the shoulder region (i.e. scapular dyskinesia), which persists even after the peripheral nerve damage has recovered. This suggests that persistent scapular dyskinesia in NA may result from (mal)adaptive changes in the central motor system.

Clinical experience shows that the specific, multidisciplinary and personalized rehabilitation program, focused on cognitive motor control can restore scapular dyskinesia in NA patients. This indicates that impairments in the central motor system likely play a role in persistent scapular dyskinesia and that specific rehabilitation may restore any alterations in central motor control.

We hypothesize that the specific rehabilitation program, focused on cognitive motor control is more effective in improving functional disability than usual care and that it can reverse maladaptive changes in central motor control.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands
        • Radboud University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • (Suspected) diagnosis of neuralgic amyotrophy
  • In subacute or chronic phase of neuralgic amyotrophy (>2 months after attack onset)
  • Right-handed
  • Neuralgic amyotrophy predominantly present in right upper extremity
  • Presence of scapular dyskinesia

Exclusion Criteria:

  • Patients in the acute phase of NA (characterized by severe pain and inflammation of the brachial plexus)
  • (Prior) NA attacks of the lumbosacral plexus or the left upper extremity
  • Sever comorbidity
  • Any (bio)mechanical constraints of the shoulder girdle
  • Any other central nervous system, neurological, or neuromuscular disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Specific rehabilitation program
Specific, personalized, multidisciplinary rehabilitation program consisting of physical- and occupational therapy.
Behavioral: Specific rehabilitation program
17-week specific and personalised rehabilitation program. The program starts with a visit to the Plexus out patient clinic in week 1. During this visit, the patient will be examined by a multidisciplinary team, consisting of a rehabilitation physician, neurologist, physical therapist and occupational therapist, which will form a rehabilitation treatment plan. This treatment plan is implemented through 4 weekly sessions in week 2-5, 2 biweekly sessions in week 6-9 and 2 monthly sessions in week 10-17 . Each treatment session involves one hour of physical- and one hour of occupational therapy.
Other: Usual Care
Usual care for people with neuralgic amyotrophy, may vary per individual
Behavioral: Specific rehabilitation program
17-week specific and personalised rehabilitation program. The program starts with a visit to the Plexus out patient clinic in week 1. During this visit, the patient will be examined by a multidisciplinary team, consisting of a rehabilitation physician, neurologist, physical therapist and occupational therapist, which will form a rehabilitation treatment plan. This treatment plan is implemented through 4 weekly sessions in week 2-5, 2 biweekly sessions in week 6-9 and 2 monthly sessions in week 10-17 . Each treatment session involves one hour of physical- and one hour of occupational therapy.
Other: Usual Care
Participants will receive their usual care for 17 weeks, which may vary for each individual

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Shoulder Rating Questionnaire (SRQ) score from baseline
Time Frame: Baseline (0 weeks) and post-intervention (17 weeks)
Change in functional (dis)ability of the shoulder, arm and hand measured with the SRQ
Baseline (0 weeks) and post-intervention (17 weeks)
Change in brain activity related to central motor control from baseline
Time Frame: Baseline (0 weeks) and post-intervention (17 weeks)
Change in the magnitudes of mean functional Magnetic Resonance Imaging signal (Blood-oxygen-level dependent (BOLD) activity) related to motor imagery of the affected arm, quantifying changes in central motor control
Baseline (0 weeks) and post-intervention (17 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in performance on motor imagery tasks assessing motor control
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in performance on motor imagery tasks. Performance is evaluated by means of reaction times and error rates.
Baseline (0 weeks), post-intervention (17 weeks)
Change in Disability of Shoulder, Arm and Hand (DASH) score from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in functional (dis)ability of the shoulder, arm and hand measured with the DASH
Baseline (0 weeks), post-intervention (17 weeks)
Change in Checklist individual strength - subscale fatigue (CIS-fatigue) score from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in experienced fatigue
Baseline (0 weeks), post-intervention (17 weeks)
Change in McGill Pain Questionnaire (MPQ) score from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in nature, intensity, location, course, and effect on daily life of experienced pain
Baseline (0 weeks), post-intervention (17 weeks)
Change in self-efficacy for performing energy conservation strategies assessment (SEPECSA) score from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in patient's perceived ability to apply energy conservation strategies to their daily life
Baseline (0 weeks), post-intervention (17 weeks)
Change in Utrecht scale for evaluation of rehabilitation-participation (USER-P) score from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in patient's participation
Baseline (0 weeks), post-intervention (17 weeks)
Change in Pain self efficacy questionnaire (PSEQ) score from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in confidence people with ongoing pain have in performing activities while in pain.
Baseline (0 weeks), post-intervention (17 weeks)
Change in Patient activation measure (PAM) score from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in knowledge, skills and confidence in managing one's own health and/or disease
Baseline (0 weeks), post-intervention (17 weeks)
Change in Short-form 36 (SF-36) score from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in experienced health and health related quality of life
Baseline (0 weeks), post-intervention (17 weeks)
Change in serratus anterior muscle strength from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in maximal force exerted with the serratus anterior muscle from baseline, measured when reaching with extended arm and flexed arm
Baseline (0 weeks), post-intervention (17 weeks)
Change in shoulder endorotation strength from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in maximal force exerted while endorotating the shoulder
Baseline (0 weeks), post-intervention (17 weeks)
Change in shoulder exorotation strength from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in maximal force exerted while exorotating the shoulder
Baseline (0 weeks), post-intervention (17 weeks)
Change in key grip strength from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in maximal force exerted while performing a key grip
Baseline (0 weeks), post-intervention (17 weeks)
Change in pinch grip strength from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in maximal force exerted while performing a pinch grip
Baseline (0 weeks), post-intervention (17 weeks)
Change in hand grip strength from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Change in maximal force exerted while performing a hand grip
Baseline (0 weeks), post-intervention (17 weeks)
Change in reachable workspace from baseline
Time Frame: Baseline (0 weeks), post-intervention (17 weeks)
Reachable workspace is an objective measure of upper extremity impairment. Reachable workspace is quantified by the relative surface area representing the portion of the unit hemisphere that is covered by the hand movements made during a standardized movement protocol which covers cardinal movements of the shoulder
Baseline (0 weeks), post-intervention (17 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Princess Beatrix Muscle Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan T Groothuis, PhD, MD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 104752

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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