Involvement of Reorganization of Cerebral Functional Connectivity in the Process of Transition to Postherpetic Neuralgia

NCT03106896 | Unknown

• 1 other identifier: 2016-069
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postherpetic neuralgia(PHN) is a chronic neuropathic pain syndrome which persists more than 3 months after the resolution of the acute shingles episode. PHN is a complicated neuropathic pain that results from the sustained peripheral injury by herpes zoster and its pathological mechanism in skin and spine has been reported. But the cerebral mechanism is still unclear. Based on the previous study that has proved the reorganization of cerebral functional connectivity in pain chronicity, the investigators hypothesize that the process from acute herpetic pain (AHP) to PHN is also accompanied with the reorganization of functional connectivity.In the study, the investigators intend to use 7 Tesla functional magnetic resonance imaging(fMRI) to observe the difference of brain activity and functional connectivity between acute herpetic pain and PHN. Meanwhile, the investigators examine the evolution of functional connectivity longitudinally in patients who is suffering from acute pain, so as to explore the central mechanism of transition to PHN.

Conditions

Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• functional connectivity between several brain regions

  The functional connectivity between several brain regions in AHP group and PHN group is different. Besides, the reorganization of cerebral functional connectivity in the process of transition to postherpetic neuralgia is relevant with the chronicity of symptom.

  AHPand CON subjects are scanned at four visits over the course of six months to observe the variation trend of connectivity from the AHP to PHN. PHN group need only one scanning.

Study Arms (3)

postherpetic neuralgia (PHN group)

persist more than 3 months after the resolution of the acute shingles episode and have pain intensity greater than 4 on the visual analog scale (VAS 0, no pain; 10, "worst pain imaginable").

acute herpetic pain (AHP group)

have pain (VAS≧4 ) duration of within 7 days after zoster onset at initial interview

healthy control (CON group)

healthy population

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The PHN sample size is determined according to the published reports. The AHP sample size is determined according to the 20.6% incidence of patients who translate from AHP to PHN and the drop-out rate, generally speaking, about 10%. Finally, we determine we need 54 AHP subjects, 10 PHN subjects, 11 age and gender-matched control subjects.

You may qualify if:

• All participants are more than 50 years old, right-handed. Patients are definitely diagnosed by a clinician for postherpetic neuralgia (PHN), persisting pain more than 3 months after the resolution of the acute shingles episode and have pain intensity greater than 4 on the visual analog scale (VAS 0, no pain; 10, "worst pain imaginable"). Patients who are diagnosed as acute herpes zoster at the initial interview have pain (VAS≧4 ) duration of within 7 days after zoster onset. Data are available for healthy control subjects with age and sex matched.

You may not qualify if:

• Subjects are excluded if they are suffering from eyes, ears, viscera, meninx herpes zoster and asymptomatic special herpes zoster. Those who report any other acute and chronic painful conditions, systemic disease, history of head injury, psychiatric diseases, or more than mild depression \[(score \> 19, according to Beck's Depression Inventory (BDI)\] are also excluded. Subjects are excluded if they were found abnormal signal when scanning by fMRI and exist MRI contraindication, such as existence of magnetic metal in body, claustrophobia and so on. Patients who don't withdraw the analgesic medication (oxycodone, NSAIDS, gabapentin, etc.) the day before and on the day of examination are also excluded.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2017
• First Posted: April 11, 2017
• Study Start: April 1, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 11, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share