Evaluation of brain connections in patients suffering from facial pai

Not Applicable

Conditions: Health Condition 1: G500- Trigeminal neuralgia

Registration Number: CTRI/2024/08/071875

Lead Sponsor: ational Institute of Mental Health and Neurosciences (NIMHANS)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Inclusion criteria for patients with Trigeminal Neuralgia (TN):

Patients with diagnosis of TN with significant pain, i.e., Barrow Neurological Institute scale score (BNI) of 4 and 5) and giving consent for functional near infrared spectroscopy (fNIRS) and heart rate variability (HRV) recordings.

Patients who are likely to undergo radiofrequency ablation (RFA) and are unwilling for surgery for treatment of TN, (when patients are refractory to medical management by atleast 2 drugs of optimal dose or developed side effects to drugs) in future, will be recruited in to the study.

Inclusion criteria for controls: Age and gender matched volunteers, aged 35-60 years of both sexes will be included as controls.

Exclusion Criteria

Absence of patient consent, inability to perform fNIRS or HRV studies, patients who are likely to undergo surgery or gamma knife radiosurgery for treatment of TN if pain persists.

For controls: Volunteers with any type of chronic pain or if they are on any medications which can modulate the brain connectivity patterns will be excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain activity and functional connectivity networks at resting state.Timepoint: At visit to pain clinic

Secondary Outcome Measures

Name	Time	Method
1. Brain functional connectivity networks in patients with TN during spontaneously evoked pain states. <br/ ><br> 2. Change in functional connectivity networks in patients with TN before and after RFA. <br/ ><br> 3. Change in HRV (as a measure of Autonomic dysfunction) in patients of TN before and after RFA. <br/ ><br> 4. The quality of life [QOL] (using EQ-5D5L questionnaire), anxiety, depression (using Hospital Anxiety and Depression Scale [HADS]) and quality of sleep using Richard Campbell sleep questionnaire, in patients with TN before and after RFA. <br/ ><br> <br/ ><br>Timepoint: 1. At OPD visit to pain clinic <br/ ><br>2, 3 and 4: Before RFA and 4-6 weeks after RFA <br/ ><br>