Functional Magnetic Resonance Imaging of Brain Activity in Patients With Painful Diabetic Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-05

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients with painful diabetic neuropathy (PDN) often combine with anxiety and depression. However, the pathogenesis of PDN is unclear, especially the mechanism associated with central nervous system. The investigators used fraction Amplitude of Low Frequency Fluctuation (fALFF) and Regional Homogeneity (ReHo) of resting-state functional Magnetic Resonance Imaging (rs-fMRI) to explore the brain activity in patients with PDN in order to study the central mechanism.The investigators evaluated the symptoms, signs and mental conditions of patients with PDN and non-pain neuropathy. The brain Blood Oxygen Level Dependent (BOLD) fMRI scan was performed in patients together with some gender and age matched healthy controls. Maybe this study can find that patients with PDN have abnormal brain activity, indicating central nervous system may contribute to painful diabetic neuropathy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Brain Network fMRI Analysis in Proprioceptive Training for Chronic Low Back Pain

NCT07308249

Brain Network Functional Connectivity

NOT_YET_RECRUITING

Combining fMRI and tDCS in Neuropathic Pain

NCT06237075

Neuropathic Pain

RECRUITING NA

A Spinal Functional Magnetic Resonance Imagine (fMRI) Study of Resting-State, Motor Task and Acupoint Stimulation

NCT00629655

Cerebral Infarction

COMPLETED

Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity

NCT02858466

Neuropathic Pain

TERMINATED NA

Quantitation of Glymphatic Functioning in Sleep and Meditative States

NCT04506892

Parkinson Disease Sleep

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Painful Diabetic Neuropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients with painful diabetic neuropathy

resting-state functional Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

The investigators used fraction Amplitude of Low Frequency Fluctuation (fALFF) and Regional Homogeneity (ReHo) of resting-state functional Magnetic Resonance Imaging (rs-fMRI) to explore the brain activity in patients with PDN in order to study the central mechanism. The investigators also evaluated the symptoms, signs and mental conditions of the patients.

diabetics with non-pain neuropathy

resting-state functional Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

The investigators used fraction Amplitude of Low Frequency Fluctuation (fALFF) and Regional Homogeneity (ReHo) of resting-state functional Magnetic Resonance Imaging (rs-fMRI) to explore the brain activity in patients with PDN in order to study the central mechanism. The investigators also evaluated the symptoms, signs and mental conditions of the patients.

gender and age matched healthy controls

resting-state functional Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

The investigators used fraction Amplitude of Low Frequency Fluctuation (fALFF) and Regional Homogeneity (ReHo) of resting-state functional Magnetic Resonance Imaging (rs-fMRI) to explore the brain activity in patients with PDN in order to study the central mechanism. The investigators also evaluated the symptoms, signs and mental conditions of the patients.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

resting-state functional Magnetic Resonance Imaging

The investigators used fraction Amplitude of Low Frequency Fluctuation (fALFF) and Regional Homogeneity (ReHo) of resting-state functional Magnetic Resonance Imaging (rs-fMRI) to explore the brain activity in patients with PDN in order to study the central mechanism. The investigators also evaluated the symptoms, signs and mental conditions of the patients.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Voluntary participation and signing informed consent
* 18 to 60 years old with junior high school education or above
* meeting the 1999 WHO type 2 diabetes diagnostic criteria: having symptoms of diabetes (polydipsia, polyphagia, polyuria and unexplained weight loss) plus one of the following 3 items: (1) random blood glucose more than 11.1 mmol/L; (2) fasting blood glucose more than 7 mmol/L; (3) after 2 hours glucose load, the blood sugar more than 11.1 mmol/L
* The diagnosis of diabetic peripheral neuropathy (at the same time meets the following three items, of which painful neuropathy patients have pain symptom): (1) neuropathy occurs not earlier than the diagnosis of diabetes; (2) having clinical manifestations of pain, numbness, and abnormal sensation; (3) any abnormality in the following 5 examinations: ankle reflex, vibratory sensation, pressure sensation, temperature sensation, and acupuncture pain

Exclusion Criteria

* left-hand writers
* neuropathy caused by other causes, such as cervical spondylosis, cerebral infarction, Green Barre syndrome; severe arteriovenous disease; neurotoxic changes caused by drugs and renal insufficiency
* patients with severe cerebral vascular disease
* diagnosed mental disorders such as depression, anxiety and Alzheimer's disease
* patients who can't accept head magnetic resonance imaging, such as those with metal (stents, metal dentures, internal fixation plates, etc.), and claustrophobic space phobias

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes