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Amygdala Insula Retraining in the Management of Multiple Sclerosis Symptoms

Amygdala Insula Retraining in the Management of Multiple Sclerosis Symptoms

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07427433
Enrollment
132
Registered
2026-02-23
Start date
2024-09-15
Completion date
2025-03-15
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Amygdala and Insula Retraining (AIR)

Brief summary

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?

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.

Interventions

Mind body brain retraining intervention

Mind body lifestyle intervention

Sponsors

Chronic Conditions Research Fund
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Confirmed multiple sclerosis diagnosis

Exclusion criteria

* Previous experience with brain retaining programs

Design outcomes

Primary

MeasureTime frame
Fatigue Severity ScaleBaseline (Week 0) to post-intervention (Week 12)

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026