An Exploration of the Neuroplasticity of Endogenous Analgesia in Health and Chronic Pain
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02572726 |
Recruitment Status :
Recruiting
First Posted : October 9, 2015
Last Update Posted : April 5, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fibromyalgia | Device: active repeated transcranial magnetic stimulation Device: 'sham' repeated transcranial magnetic stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Basic Science |
Official Title: | Integration of Neuroimaging and Transcranial Magnetic Stimulation: an Exploration of the Neuroplasticity of Endogenous Analgesia in Health and Chronic Pain |
Actual Study Start Date : | October 11, 2015 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: active rTMS
active repeated transcranial magnetic stimulation over primary motor cortex along 5-10 daily sessions
|
Device: active repeated transcranial magnetic stimulation
ten daily sessions with active 10Hz 20 min-long stimulation over the primary motor cortex |
Sham Comparator: 'sham' rTMS
'sham' repeated transcranial magnetic stimulation over primary motor cortex along 5-10 daily sessions
|
Device: 'sham' repeated transcranial magnetic stimulation
ten daily sessions with 'sham' 10Hz 20 min-long stimulation over the primary motor cortex |
- rTMS-induced change in fibromyalgia pain level [ Time Frame: through study completion, an average of 2 year ]Fibromyalgia pain level will be measured using the numerical pain scale; the patients will be asked to rate their mean pain level over the last 5 days
- treatment-induced changes of white-matter connectivity of the brain [ Time Frame: through study completion, an average of 2 year ]White-matter connectivity will be measured using the method of diffusion tensor imaging of the brain

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- a prior FMS diagnosis by a rheumatologist or pain specialist based on American College of Rheumatology (ACR) preliminary diagnostic criteria for fibromyalgia
- healthy subjects - no pain/psychiatry/neurological diseases
Exclusion Criteria:
- other chronic pain, psychiatric or neurological diseases. All will be asked to withdraw from any pain-relieving medications for 24h before the testing.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572726
Contact: David Yarnitsky, MD, Prof | +972 502062700 | ||
Contact: Yelena Granovsky, PhD | +972 502065750 |
Israel | |
Rambam Medical Center | Recruiting |
Haifa, Israel | |
Contact: David Yarnitsky, Prof. +972-4-8542605 | |
Principal Investigator: David Yarnitsky, Prof. |
Principal Investigator: | David Yarnitsky, MD, Prof | Rambam Health Care Campus |
Responsible Party: | Rambam Health Care Campus |
ClinicalTrials.gov Identifier: | NCT02572726 |
Other Study ID Numbers: |
0106-15_CTIL |
First Posted: | October 9, 2015 Key Record Dates |
Last Update Posted: | April 5, 2019 |
Last Verified: | April 2019 |
Fibromyalgia Chronic Pain Pain Neurologic Manifestations Muscular Diseases |
Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |