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

Use Resting-state Functional Magnetic Resonance Imaging (Rs-fMRI) to Explore the Brain Activity in Patients With Painful Diabetic Neuropathy (PDN) in Order to Study Central Mechanism of PDN.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03700502
Enrollment
60
Registered
2018-10-09
Start date
2016-06-05
Completion date
2018-11-30
Last updated
2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painful Diabetic Neuropathy

Keywords

resting state functional MRI, painful diabetic neuropathy

Brief summary

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.

Interventions

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.

Sponsors

Jiangsu Province Nanjing Brain Hospital
CollaboratorOTHER
Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
resting-state functional Magnetic Resonance Imagingone or two yearscollect and analyze the data of brain fMRI

Countries

China

Contacts

Primary ContactJin Dan Wu, master
wujindandan@sina.com0086-18951670336
Backup ContactQing Zhang, master
zhangqingwork@sina.com0086-15950522889

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026