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Evaluation of brain connections in patients suffering from facial pain

Evaluation of the brain functional connectivity networks using functional near infrared spectroscopy (fNIRS) in patients with trigeminal neuralgia - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/071875
Enrollment
60
Registered
2024-08-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: G500- Trigeminal neuralgia

Interventions

Intervention1: Assessment of anxiety and depression using HADS: will be performed at OPD visit and after RFA at the follow up visit (4-6 weeks later) if they undergo RFA. It will take about 5 min for

Sponsors

National Institute of Mental Health and Neurosciences (NIMHANS)
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Brain activity and functional connectivity networks at resting state.Timepoint: At visit to pain clinic

Secondary

MeasureTime frame
1. Brain functional connectivity networks in patients with TN during spontaneously evoked pain states. 2. Change in functional connectivity networks in patients with TN before and after RFA. 3. Change in HRV (as a measure of Autonomic dysfunction) in patients of TN before and after RFA. 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. Timepoint: 1. At OPD visit to pain clinic 2, 3 and 4: Before RFA and 4-6 weeks after RFA

Countries

India

Contacts

Public ContactDr Sonia Bansal

NIMHANS

itz.sonia77@gmail.com09008721921

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026