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

Painful Diabetic Neuropathy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03700502
• Other study ID #: 201605027
• Status: Recruiting
• Start date: June 5, 2016
• Est. completion date: November 2018

Study information

• Verified date: March 2018
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Jin Dan Wu, master
• Phone: 0086-18951670336
• Email: wujindandan[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Diabetic Neuropathy
• Peripheral Nervous System Diseases

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	the first hospital of Nanjing	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University	Jiangsu Province Nanjing Brain Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resting-state functional Magnetic Resonance Imaging	collect and analyze the data of brain fMRI	one or two years