Explosive Synchronization of Brain Network Activity in Chronic Pain

University of Michigan1 个研究点分布在 1 个国家目标入组 150 人2020年11月13日

适应症Fibromyalgia Healthy Volunteers

干预措施EEG Neuroimaging EEG/fMRI (Aim 1)HD-tDCS treatments Sham HD-tDCS treatments Neuroimaging EEG/fMRI (Aim 3)

概览

阶段: 不适用
干预措施: EEG
疾病 / 适应症: Fibromyalgia
发起方: University of Michigan
入组人数: 150
试验地点: 1
主要终点: Aim 1 - Brain EEG metric of ES obtained at Visit 1: Correlation between EEG alpha band degree and frequency.
状态: 招募中
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This project is being conducted to evaluate the impact of explosive synchronization (ES) and its treatment with non-invasive brain stimulation in fibromyalgia (FM). The study design has three components, however, only 2 aims are enrolling participants. The first part (Aim1) is a cross sectional assessment of brain network explosive synchronization activity, connectivity, and response to pain in healthy controls and age and sex-matched fibromyalgia patients; the third part (Aim 3) is a longitudinal assessment of fibromyalgia patients undergoing one week of sham followed by high-definition transcranial direct current stimulation (HD-tDCS) of the motor cortex (M1) or one week of ES HD-tDCS of a brain region identified from computer modelling (Aim 2).

详细描述

In the first part healthy controls (25 female/10 males) and fibromyalgia (25 female/10 males) participants that are enrolled in this phase will have 3 visits as well as a run-in observational period (up to a total of 33 days). During this time, participants will complete surveys, as well as have electroencephalograms (EEG) with quantitative sensory testing and functional Magnetic resonance imaging (fMRI). Hypothesis: FM patients will display greater ES in the brain, compared to pain-free controls when assessed with EEG at rest. Furthermore, patients experiencing increased clinical pain, will display increases in ES metrics In the third part FM patients will be enrolled (50) and receive treatment with either sham treatment followed by M1 HD-tDCS or sham treatment followed by ES HD-tDCS. These participants will also complete surveys and have neuroimaging EEG/MRI. Hypothesis: Following a course of HD-tDCS targeted at either A.) the motor cortex (M1) or B.) an ES-sensitive region identified in Aim 2, FM patients will display decreased strength of ES conditions (correlation between node degree and frequency) as compared to Sham, when assessed with EEG. Moreover, the degree of pain reduction following HD-tDCS will correlate with the amount of reduction in these network parameters leading to ES. If unable to identify an ES-sensitive region using computer modeling in Aim 2, our hypothesis for motor cortex stimulation is that HD-tDCS at M1 will result in decreased ES conditions as compared to Sham, when assessed with EEG. After consultation with and approval by NIH from September through November 2024, and IRB approval in January 2025, the testing involved for outcome measures 5 and 6 was removed for future participants, thus effectively demoting those outcome measures to exploratory.

注册库

clinicaltrials.gov

开始日期

2020年11月13日

结束日期

2026年7月20日

最后更新

上个月

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

University of Michigan

责任方

Principal Investigator

主要研究者

Alexandre DaSilva, DDS, DMedSc

Professor of Dentistry

University of Michigan

入排标准

入选标准

•For Fibromyalgia Participants:
•Satisfy the American College of Rheumatology (2011) survey criteria for the classification of Fibromyalgia (FM).
•Continued presence of pain for more than 50% of days for the past month.
•Mean recalled pain over the last seven days (7-day recall) greater than or equal to 3 on a 10 centimeter (cm) Visual Analog Scale (VAS) for pain; 7-day recall
•Willing to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study.
•Right-handed.
•Able to travel to the study site to receive (HD-tDCS) treatments five times weekly
•Understanding and willing to complete all study procedures.
•Capable of giving written informed consent.
•Inclusion Criteria for Healthy Control Participants:

排除标准

•for Fibromyalgia Participants:
•Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, et cetera (etc.) that causes pain.
•History of head injury with substantial loss of consciousness
•Peripheral neuropathy of known cause that interferes with activities of daily living.
•Routine daily use of opioid analgesics, marijuana, or history of substance abuse.
•Stimulant medications, such as those used to treat attention-deficit/hyperactivity disorder (ADHD)/Attention deficit disorder (ADD) (for example (e.g.), amphetamine/ dextroamphetamine \[Adderall®\], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded.
•Concurrent participation in other therapeutic trials.
•Use of as needed (PRN) over the counter (OTC) pain medications (Nonsteroidal anti-inflammatory drugs (NSAIDs), etc.) on day of electroencephalogram (EEG)/Magnetic resonance imaging (MRI).
•Use of PRN opioid analgesics 48 hours prior to EEG/MRI scan.
•Pregnant or nursing. A pregnancy test will be given prior to EEG/MRI sessions.

研究组 & 干预措施

Aim 1 - Healthy control

Participants will have three visits for this part along with a run-in observation period. An EEG with Quantitative Sensory Testing (QST) will be performed at visit 1 along with other measures. Additionally, the an MRI will be done at visit 2 along with other measures.

干预措施: EEG

Aim 1 - Healthy control

干预措施: Neuroimaging EEG/fMRI (Aim 1)

Aim 1 - Fibromyalgia participant

干预措施: EEG