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taVNS Treatment for Fibromyalgia

Primary Purpose

Fibromyalgia

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Auricular transcutaneous electrical nerve stimulation device

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring taVNS, Pain, Neuromodulation, Fibromyalgia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Meet the American College of Rheumatology (ACR) 1990 classification criteria and the ACR 2010 diagnostic criteria for fibromyalgia as determined by clinicians.
Willingness to complete a 4-week, twice-a-day treatments.
At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.

Exclusion Criteria:

Diagnosed with medical conditions that are known to contribute to fibromyalgia symptomatology, such as thyroid disease, inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis, or Sjogren's syndrome.
History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia.
Personal history of medical or psychiatric illness as determined by investigator.
Pregnant or lactating.
Less than a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

taVNS Group1

taVNS Group 2

Arm Description

This group will receive taVNS for 4 weeks.

Outcomes

Primary Outcome Measures

Revised Fibromyalgia Impact Questionnaire (FIQR)

A change in the FIQR would indicate that participants are experiencing pain relief.

Secondary Outcome Measures

Patient Reported Outcomes Measurement Information System (PROMIS-29)

Pain Catastrophizing Scale

Beck Depression Inventory-II (BDI-II)

Brief Quantitative Sensory Testing (QST)

Heart rate variability

power of oscillations in the alpha, theta, and gamma frequencies (optional)

6 minutes of resting state EEG (with eyes open) (Optional). We will calculate the power of oscillations in the alpha, theta, and gamma frequencies, which will be normalized by the mean power for the global spectrum.

Blood inflammation markers (optional)

We will examine inflammatory mediators such as interleukins (ILs including IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, and IL-10), IFN-γ, and tumor necrosis factor (TNF) via multiplex immunoassays using Luminex, as well as highly sensitive C-reactive protein (hsCRP), programmed death 1 (PD-1), prostaglandin E2, and BDNF.

Full Information

NCT ID

NCT04777500

First Posted

February 17, 2021

Last Updated

August 30, 2021

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04777500

Brief Title

taVNS Treatment for Fibromyalgia

Official Title

Applying Transcutaneous Auricular Vagus Nerve Stimulation to Treat Fibromyalgia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 30, 2021 (Anticipated)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In this research study we want to learn more about if transcutaneous electrical nerve stimulation (TENS), a safe electrical stimulation tool, can relieve Fibromyalgia pain. A total of 60 subjects with Fibromyalgia will be enrolled in this study at Massachusetts General Hospital, Charlestown Navy Yard campus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

taVNS, Pain, Neuromodulation, Fibromyalgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

taVNS Group1

Arm Type

Experimental

Arm Description

This group will receive taVNS for 4 weeks.

Arm Title

taVNS Group 2

Arm Type

Experimental

Arm Description

This group will receive taVNS for 4 weeks.

Intervention Type

Device

Intervention Name(s)

Auricular transcutaneous electrical nerve stimulation device

Intervention Description

We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.

Primary Outcome Measure Information:

Title

Revised Fibromyalgia Impact Questionnaire (FIQR)

Description

A change in the FIQR would indicate that participants are experiencing pain relief.

Time Frame

Baseline, week 2 and week 4.

Secondary Outcome Measure Information:

Title

Patient Reported Outcomes Measurement Information System (PROMIS-29)

Time Frame

Baseline, week 2 and week 4.

Title

Pain Catastrophizing Scale

Time Frame

Baseline, week 2 and week 4.

Title

Beck Depression Inventory-II (BDI-II)

Time Frame

Baseline and week 4.

Title

Brief Quantitative Sensory Testing (QST)

Time Frame

Baseline and week 4.

Title

Heart rate variability

Time Frame

Baseline and week 4.

Title

power of oscillations in the alpha, theta, and gamma frequencies (optional)

Description

Time Frame

Baseline and week 4.

Title

Blood inflammation markers (optional)

Description

Time Frame

Baseline and week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meet the American College of Rheumatology (ACR) 1990 classification criteria and the ACR 2010 diagnostic criteria for fibromyalgia as determined by clinicians. Willingness to complete a 4-week, twice-a-day treatments. At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures. Exclusion Criteria: Diagnosed with medical conditions that are known to contribute to fibromyalgia symptomatology, such as thyroid disease, inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis, or Sjogren's syndrome. History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia. Personal history of medical or psychiatric illness as determined by investigator. Pregnant or lactating. Less than a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maya Eshel, BA

Phone

(617) 726-5004

meshel@mgh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Kong

Organizational Affiliation

MGH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Charlestown

State/Province

Massachusetts

ZIP/Postal Code

02129-2020

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maya Eshel

meshel@mgh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Rachel Dao

rdao@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD

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taVNS Treatment for Fibromyalgia

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