Targeted Limbic Self-modulation as a Potential Treatment for Patients Suffering From Fibromyalgia

NCT02146495 | Completed

• 1 other identifier: TASMC-14-HS-0044-CTIL
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to test whether voluntary regulation of limbic system activation is possible in patients with fibromyalgia and to examine the neurobehavioral effects of specific neuromodulation of this circuit on somatosensory, limbic, and cognitive processes. This goal will be achieved by using a method previously developed for the construction of an fMRI-enriched EEG model ("EEG-Finger-Print", EFP) that selectively targets the amygdala BOLD activation (Amyg-EFP). The investigators conducted two studies: In the first study, the investigators conducted simultaneous recordings of EEG and fMRI during Amyg-EFP NF training on patients with FM. The main objective is to demonstrate target engagement following Amyg-EFP-NF training in FM patients. In the second study, the investigators aim to conduct a randomized clinical trial to examine the causal effect of the Amyg-EFP NF trial. The investigators will compare neurobehavioral effects between three groups. I. Amyg-EFP-NF group: a multisession NF trial using the Amyg-EFP model. II. Control group 1- sham-NF: a multisession NF trial using sham feedback. III. Control group 2: patients in this group will continue their usual treatment without intervention.

Conditions

Fibromyalgia (FM)

Keywords

Fibromyalgia, neurofeedback, fMRI, EEG

Outcome Measures

Primary Outcomes (12)

• Clinical improvement using the Fibromyalgia Impact Questionnaire (FIQ) to evaluate FM symptoms

  Scoring from 0 (no impairment) to 80 (maximum), with subscales ranging up to 10 (maximum).

  Immediately post-intervention relative to the baseline level

• Clinical improvement using the Symptom Severity Score (SSS)

  Ranges from 0 to 12 (highest severity).

  Immediately post-intervention relative to the baseline level

• Clinical improvement using the Widespread Pain Index (WPI)

  Ranges from 0 to 19 (highest level of pain distribution).

  Immediately post-intervention relative to the baseline level

• Clinical improvement using the SF-36 Health Survey (SF-36) to evaluate daily impacts of FM

  Scores from 0 to 100 (higher scores indicate better health).

  Immediately post-intervention relative to the baseline level

• Clinical improvement using the Trait Anxiety Inventory (STAI-T) to evaluate the level of anxiety

  Ranges from 20 to 80 (highest anxiety level).

  Immediately post-intervention relative to the baseline level

• Clinical improvement using the Beck Depression Inventory (BDI) to evaluate the level of depression

  Ranges from 0 to 63 (highest depression level).

  Immediately post-intervention relative to the baseline level

• Long-term clinical improvement using the Fibromyalgia Impact Questionnaire (FIQ) to evaluate FM symptoms

  Scoring from 0 (no impairment) to 80 (maximum), with subscales ranging up to 10 (maximum).

  Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)

• Long-term clinical improvement using the Symptom Severity Score (SSS)

  Ranges from 0 to 12 (highest severity).

  Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)

• Long-term clinical improvement using the Widespread Pain Index (WPI)

  Ranges from 0 to 19 (highest level of pain distribution).

  Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)

• Long-term clinical improvement using the SF-36 Health Survey (SF-36) to evaluate daily impacts of FM

  Scores from 0 to 100 (higher scores indicate better health).

  Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)

• Long-term clinical improvement using the Trait Anxiety Inventory (STAI-T) to evaluate the level of anxiety

  Ranges from 20 to 80 (highest anxiety level).

  Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)

• Long-term clinical improvement using the Beck Depression Inventory (BDI) to evaluate the level of depression

  Ranges from 0 to 63 (highest depression level).

  Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)

Secondary Outcomes (1)

• Neural Prediction

  Through study completion, an average of 2 year

Other Outcomes (4)

• Brain pattern Changes

  Change in neural pattern immediately post-intervention relative to the baseline level (Post-intervention vs. Baseline)

• Amyg-EFP-NF regulation success

  1-10 weeks

• Pain Assessment

  Change in pain level immediately post-intervention relative to the baseline level (Post-intervention vs. Baseline)

Study Arms (4)

Simultaneous EEG/ fMRI Recordings during Amyg-EFP-NF

EXPERIMENTAL

Patients with FM will undergo concurrent EEG and fMRI recordings. During the fMRI scans, they will engage in Amyg-EFP NF training.

Device: Simultaneous EEG and fMRI recordings

Amyg-EFP-NF Trial

ACTIVE COMPARATOR

The EFP-NF procedure will include a multisession NF trial (10 sessions) using feedback driven by the Amyg-EFP model.

Device: Amygdala-Electrical Fingerprint (Amyg-EFP)-NF Trial

Amyg-EFP-NF Sham Trial

SHAM COMPARATOR

The sham NF procedure will include a multisession NF trial (10 sessions) using sham feedback; in this condition, the feedback will be provided based on a randomized Amyg-EFP signal.

Device: Amygdala-Electrical Fingerprint (Amyg-EFP)-NF Sham Trial

Treatment As Usual

NO INTERVENTION

Patients in this group will continue their usual treatment without any intervention. Patients in this control group will undergo a complete clinical and neural evaluation at the beginning and end of a defined period, similar to the NF intervention period, and a clinical follow-up (after 10-12 months).

Interventions

Simultaneous EEG and fMRI recordings DEVICE

Simultaneous EEG/ fMRI Recordings during Amyg-EFP-NF

Amygdala-Electrical Fingerprint (Amyg-EFP)-NF Trial DEVICE

Neurofeedback training utilizing Amygdala Electrical Fingerprint (Amyg-EFP) methodology

Amyg-EFP-NF Trial

Amygdala-Electrical Fingerprint (Amyg-EFP)-NF Sham Trial DEVICE

Sham neurofeedback training based on a randomized artificial Amyg-EFP signal.

Amyg-EFP-NF Sham Trial

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-55
• Fibromyalgia diagnosis by a specialist in internal medicine, Neurology or Pain medicine
• Subjective complaints about sleep disorder
• Pain does not stop despite regular medication- at least three events per week of pain ranked five out of ten
• chronic drug treatment should not be change in the near future (6 weeks).
• Hebrew speaker
• Accepted criteria for MRI scan for medical use will be followed, according to the procedures prescribed in the MRI institute of the Tel-Aviv Sourasky medical center.

You may not qualify if:

• Non-Hebrew speakers
• Diagnosis of another pain chronic syndrome or any significant medical illness.
• History of psychiatric or neurological diseases requiring hospitalization.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, N/A = Not Applicable, Israel

Location

Related Publications (1)

• Or-Borichev A, Lerner Y, Hamrani Y, Gurevitch G, Mor N, Doron M, Sarna N, Ablin JN, Hendler T, Sharon H. Targeted limbic self-neuromodulation for alleviating central sensitization symptoms in fibromyalgia. BMC Med. 2025 May 28;23(1):304. doi: 10.1186/s12916-025-04138-3.

  PMID: 40437546 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Ayelet Or-Borichev, PhD

  Sagol Brain Institute, Tel Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 23, 2014
• Study Start: January 1, 2017
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)