- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02146495
Targeted Limbic Self-modulation as a Potential Treatment for Patients Suffering From Fibromyalgia
Mechanistic Perspective on EEG Based Amygdala Driven NF in Fibromyalgia
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Haggai Sjaron, MD
- Email: haggaisharon@gmail.com
Study Locations
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N/A = Not Applicable
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Tel Aviv, N/A = Not Applicable, Israel
- Tel Aviv Sourasky Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Non-Hebrew speakers
- Diagnosis of another pain chronic syndrome or any significant medical illness.
- History of psychiatric or neurological diseases requiring hospitalization.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Simultaneous EEG/ fMRI Recordings during Amyg-EFP-NF
Patients with FM will undergo concurrent EEG and fMRI recordings.
During the fMRI scans, they will engage in Amyg-EFP NF training.
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Active Comparator: Amyg-EFP-NF Trial
The EFP-NF procedure will include a multisession NF trial (10 sessions) using feedback driven by the Amyg-EFP model.
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Neurofeedback training utilizing Amygdala Electrical Fingerprint (Amyg-EFP) methodology
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Sham Comparator: Amyg-EFP-NF Sham Trial
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.
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Sham neurofeedback training based on a randomized artificial Amyg-EFP signal.
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No Intervention: Treatment As Usual
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical improvement using the Fibromyalgia Impact Questionnaire (FIQ) to evaluate FM symptoms
Time Frame: Immediately post-intervention relative to the baseline level
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Scoring from 0 (no impairment) to 80 (maximum), with subscales ranging up to 10 (maximum).
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Immediately post-intervention relative to the baseline level
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Clinical improvement using the Symptom Severity Score (SSS)
Time Frame: Immediately post-intervention relative to the baseline level
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Ranges from 0 to 12 (highest severity).
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Immediately post-intervention relative to the baseline level
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Clinical improvement using the Widespread Pain Index (WPI)
Time Frame: Immediately post-intervention relative to the baseline level
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Ranges from 0 to 19 (highest level of pain distribution).
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Immediately post-intervention relative to the baseline level
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Clinical improvement using the SF-36 Health Survey (SF-36) to evaluate daily impacts of FM
Time Frame: Immediately post-intervention relative to the baseline level
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Scores from 0 to 100 (higher scores indicate better health).
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Immediately post-intervention relative to the baseline level
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Clinical improvement using the Trait Anxiety Inventory (STAI-T) to evaluate the level of anxiety
Time Frame: Immediately post-intervention relative to the baseline level
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Ranges from 20 to 80 (highest anxiety level).
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Immediately post-intervention relative to the baseline level
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Clinical improvement using the Beck Depression Inventory (BDI) to evaluate the level of depression
Time Frame: Immediately post-intervention relative to the baseline level
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Ranges from 0 to 63 (highest depression level).
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Immediately post-intervention relative to the baseline level
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Long-term clinical improvement using the Fibromyalgia Impact Questionnaire (FIQ) to evaluate FM symptoms
Time Frame: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
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Scoring from 0 (no impairment) to 80 (maximum), with subscales ranging up to 10 (maximum).
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Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
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Long-term clinical improvement using the Symptom Severity Score (SSS)
Time Frame: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
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Ranges from 0 to 12 (highest severity).
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Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
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Long-term clinical improvement using the Widespread Pain Index (WPI)
Time Frame: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
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Ranges from 0 to 19 (highest level of pain distribution).
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Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
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Long-term clinical improvement using the SF-36 Health Survey (SF-36) to evaluate daily impacts of FM
Time Frame: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
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Scores from 0 to 100 (higher scores indicate better health).
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Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
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Long-term clinical improvement using the Trait Anxiety Inventory (STAI-T) to evaluate the level of anxiety
Time Frame: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
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Ranges from 20 to 80 (highest anxiety level).
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Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
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Long-term clinical improvement using the Beck Depression Inventory (BDI) to evaluate the level of depression
Time Frame: Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
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Ranges from 0 to 63 (highest depression level).
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Change in symptoms at 10-12 months relative to the baseline level (Follow-up measure vs. Baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neural Prediction
Time Frame: Through study completion, an average of 2 year
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Simultaneous fMRI/EEG scan in order to identify whether the Amyg-EFP signal reliably predicts the amygdala BOLD activity
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Through study completion, an average of 2 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain pattern Changes
Time Frame: Change in neural pattern immediately post-intervention relative to the baseline level (Post-intervention vs. Baseline)
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Measured via real-time fMRI; region of interest analysis in the amygdala; comparison between post vs pre scans: change in blood-oxygen-level-dependent (BOLD) response to regulate > baseline condition during NF task.
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Change in neural pattern immediately post-intervention relative to the baseline level (Post-intervention vs. Baseline)
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Amyg-EFP-NF regulation success
Time Frame: 1-10 weeks
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Measured by change in Amyg-EFP power; based on the difference between regulate and baseline conditions during the neurofeedback cycles
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1-10 weeks
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Pain Assessment
Time Frame: Change in pain level immediately post-intervention relative to the baseline level (Post-intervention vs. Baseline)
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Quantitative Sensory Testing (QST)- which assesses somatosensory function and provides thermal pain thresholds and sensory threshold.
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Change in pain level immediately post-intervention relative to the baseline level (Post-intervention vs. Baseline)
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Sleep assessment
Time Frame: Change in sleep quality immediately post-intervention relative to the baseline level (Post-intervention vs. Baseline)
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The investigators were measured via one-night sleep monitoring using the WatchPAT-200 device. While the specific range scores for sleep latency and sleep efficiency using the WatchPAT-200 are not explicitly detailed in the available documentation, it's generally accepted in sleep studies that normal sleep efficiency is considered to be 85% or higher. Normal sleep onset latency typically ranges from 10 to 25 minutes. To evaluate sleep quality, the investigators calculate a combined score using two sleep metrics: sleep latency and sleep efficiency. |
Change in sleep quality immediately post-intervention relative to the baseline level (Post-intervention vs. Baseline)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayelet Or-Borichev, PhD, Sagol Brain Institute, Tel Aviv Sourasky Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-14-HS-0044-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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