Amygdala Insula Retraining in the Management of Multiple Sclerosis Symptoms

February 16, 2026 updated by: Chronic Conditions Research Fund

The goal of this study is to compare a lifestyle intervention and a mind-body intervention against a wait-list control in individuals with multiple sclerosis experiencing persistent symptoms.

Our research questions include:

Are lifestyle and mind-body interventions additive to usual care in MS?

Can these interventions improve MS symptoms and overall quality of life?

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

Multiple sclerosis (MS) is a chronic, immune-mediated neurological condition characterized by inflammation and neurodegeneration within the central nervous system. Despite advances in disease-modifying therapies, many individuals with MS continue to experience persistent and disabling symptoms, including fatigue, cognitive dysfunction, pain, mood disturbance, autonomic dysregulation, sleep disruption, and reduced quality of life. These symptoms often fluctuate and may persist independent of inflammatory disease activity, underscoring the need for adjunctive, non-pharmacologic interventions that target symptom burden and functional outcomes.

This study evaluates two distinct educational interventions designed to support symptom management in individuals with MS: a comprehensive lifestyle education program and a neuroplasticity-based brain retraining program known as Amygdala and Insula Retraining (AIR). Lifestyle-focused interventions targeting stress management, nutrition, sleep, physical activity, and environmental exposures have demonstrated benefits across chronic illness populations and are increasingly recognized as important components of comprehensive MS care. In parallel, growing evidence supports the role of mind-body approaches in modulating autonomic nervous system function, stress, and measurable effects on fatigue, mood, pain, quality of life, and heart rate variability.

AIR is based on the principle that chronic illness and inflammatory stressors may sensitize neural circuits involved in threat detection and interoception, particularly the amygdala and insula, leading to persistent hypervigilance and maladaptive autonomic signaling. In MS, this heightened neural reactivity may contribute to symptom amplification such as increased fatigue, dysautonomia, and reduced stress resilience. AIR aims to de-sensitize these neural pathways through structured neuroplasticity-based cognitive and mindfulness practices, with the goal of interrupting maladaptive feedback loops and supporting improved autonomic and emotional regulation.

In this randomized pilot study, individuals with MS will be assigned to one of three groups: a lifestyle education program, the AIR program, or a wait-list control group. By comparing changes in validated symptom and quality-of-life measures across groups over time, this study aims to generate preliminary data on the feasibility and potential symptom-modifying effects of both interventions, informing the design of larger, controlled trials.

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.
132

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

  • United States
    • Iowa
      • Decorah, Iowa, United States, 52101
        • Luther College Department of Psychology

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed multiple sclerosis diagnosis

Exclusion Criteria:

  • Previous experience with brain retaining programs

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: Parallel 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.
No Intervention: Control
Experimental: Amygdala insula retraining
Mind body amygdala insula retraining intervention delivered virtually + usual care
Behavioral: Amygdala insula retraining
Mind body brain retraining intervention
Experimental: Lifestyle program
Mind body lifestyle intervention
Behavioral: Lifestyle program
Mind body lifestyle intervention

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
Time Frame
Fatigue Severity Scale
Time Frame: Baseline (Week 0) to post-intervention (Week 12)
Baseline (Week 0) to post-intervention (Week 12)

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
Time Frame
PROMIS Pain Interference 8a
Time Frame: Baseline (Week 0) to post-intervention (Week 12)
Baseline (Week 0) to post-intervention (Week 12)
EQ-5D (quality of life)
Time Frame: Baseline (Week 0) to post-intervention (Week 12)
Baseline (Week 0) to post-intervention (Week 12)
GAD-7 (anxiety)
Time Frame: Baseline (Week 0) to post-intervention (Week 12)
Baseline (Week 0) to post-intervention (Week 12)
PHQ-9 (depression, with suicidality item excluded)
Time Frame: Baseline (Week 0) to post-intervention (Week 12)
Baseline (Week 0) to post-intervention (Week 12)
MSQ-Revised (exploratory)
Time Frame: Baseline (Week 0) to post-intervention (Week 12)
Baseline (Week 0) to post-intervention (Week 12)

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.
Chronic Conditions Research Fund

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.
September 15, 2024

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.
March 15, 2025

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.
March 15, 2025

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 16, 2026

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 16, 2026

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 23, 2026

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.
February 23, 2026

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.
February 16, 2026

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.
February 1, 2026

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.
  • CCRF-AIR-MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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