## Protocol Section
### Identification Module
**NCT ID:** NCT06416826

**Brief Title:** Rhythmic Sensory Stimulation on Fibromyalgia

**Official Title:** An Investigation of the Effects of Rhythmic Sensory Stimulation on Fibromyalgia

#### Organization Study ID Info
**ID:** FibroMusicTherapy
#### Organization
**Class:** OTHER
**Full Name:** Women's College Hospital
### Status Module
#### Completion Date
**Date:** 2020-03-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2020-03-01

**Type:** ACTUAL

#### Start Date
**Date:** 2019-04-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2019-04-08
**Study First Submit QC Date:** 2024-05-10
**Why Stopped:** unforeseen circumstances
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Toronto

#### Lead Sponsor

**Class:** OTHER

**Name:** Women's College Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this project is to further examine the effectiveness of Rhythmic Sensory Stimulation (RSS) with low-frequency sounds and somatosensory stimulation as a complementary therapy for fibromyalgia, and to investigate potential mechanisms underlying the effects of RSS on chronic pain.

### Conditions Module

**Conditions:**

- Chronic Pain, Widespread

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** healthy controls

n = 10

**Label:** control

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** patients with fibromyalgia

n =20

**Intervention Names:**

- Device: Vibroacoustic Therapy System - VTS 1000

**Label:** patients

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- patients

**Description:** Participants will undertake 15 self-administered sessions of RSS 40Hz low frequency sound stimulation, 30 minutes daily, over 3 weeks (5 days/week).

**Name:** Vibroacoustic Therapy System - VTS 1000

**Other Names:**

- Rhythmic Sensory Stimulation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The investigator will use a multiplex enzyme-linked immunosorbent assay (ELISA) to asses inflammatory cytokines in fibromyalgia.

**Measure:** change in inflammatory cytokine levels

**Time Frame:** baseline, 1 month, 2 months

#### Secondary Outcomes

**Description:** Patients will rate their pain severity on a scale from 0 (no pain) to 10 (extreme pain)

**Measure:** change in pain severity

**Time Frame:** baseline, 1 month, 2 months

**Description:** The investigators will measure EEG dynamics to quantify dysfunctional activity in brain areas that are affected by fibromyalgia

**Measure:** change in EEG brain activity

**Time Frame:** baseline, 1 month, 2 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* patients with clinical diagnosis of fibromyalgia
* able to read and write English adequately
* have satisfactory hearing bilaterally (self-reported)
* have the ability to operate the supplied device

Exclusion Criteria:

* acute and active inflammatory conditions (e.g., rheumatoid arthritis, osteoarthritis, autoimmune disease)
* medical or psychiatric illness
* history of psychosis, epilepsy, seizures
* pregnancy or breast feeding
* hemorrhaging or active bleeding
* thrombosis, angina pectoris
* heart disease, such as hypotension, arrhythmia, pacemaker
* substance abuse (harmful or hazardous use of psychoactive subtances, including alcohol and illicit drugs) in the last year
* suffering from a recently prolapsed vertebral disc
* recovering from a recent accident with back or neck injury.

**Gender Based:** True

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M29442

- Name: Chronic Pain

- Relevance: HIGH

- As Found: Chronic Pain, Widespread

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M8486

- Name: Fibromyalgia

- Relevance: HIGH

- As Found: Fibromyalgia

- ID: M12161

- Name: Myofascial Pain Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005356

- Term: Fibromyalgia

- ID: D000059350

- Term: Chronic Pain

### Misc Info Module

- Version Holder: 2024-05-31
