| CTRI Number |
CTRI/2024/08/071875 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of brain connections in patients suffering from facial pain |
|
Scientific Title of Study
|
Evaluation of the brain functional connectivity networks using functional near infrared spectroscopy (fNIRS) in patients with trigeminal neuralgia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonia Bansal |
| Designation |
Additional Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neuroanaesthesia and Neurocritical Care, 3rd floor, Faculty Block, Neurocentre, NIMHANS (near Bangalore Milk Dairy), Bengaluru 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
09008721921 |
| Fax |
|
| Email |
itz.sonia77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Bansal |
| Designation |
Additional Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neuroanaesthesia and Neurocritical Care, 3rd floor, Faculty Block, Neurocentre, NIMHANS (near Bangalore Milk Dairy), Bengaluru 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
09008721921 |
| Fax |
|
| Email |
itz.sonia77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonia Bansal |
| Designation |
Additional Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neuroanaesthesia and Neurocritical Care, 3rd floor, Faculty Block, Neurocentre, NIMHANS (near Bangalore Milk Dairy), Bengaluru 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
09008721921 |
| Fax |
|
| Email |
itz.sonia77@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences (NIMHANS), Near Dairy circle, Hosur Road, Bengaluru 560029, INDIA |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Hosur road, Nar Bangalore milk dairy, Bengaluru-560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonia Bansal |
National Institute of Mental Health and Neurosciences (NIMHANS) |
Department of Neuroanaesthesia and Neurocritical Care, 3rd floor, Faculty Block, Neurocentre, NIMHANS (near Bangalore Milk Dairy), Bengaluru 560029
Bangalore
KARNATAKA |
09008721921
itz.sonia77@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstituteEthicsCommitteeBSNS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Brain connectivity patterns will be compared between patients of Trigeminal Neuralgia and healthy volunteers aged 35-60 years, of both sexes |
| Patients |
(1) ICD-10 Condition: G500||Trigeminal neuralgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 each assessment.
|
| Intervention |
Assessment of QoL using European Quality of Life – 5D-5L dimension |
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 each assessment.
|
| Intervention |
fNIRS
|
fNIRS recording of 5-10 minutes will be performed for volunteers (at any convenient time, resting state) and for patients with TN at OPD visit (in the resting state and with pain in patients with TN if spontaneous pain occurs). FNIRS will be repeated in patients with TN if they undergo RFA, at the follow up visit (4-6 weeks later)
|
| Intervention |
Heart rate varaiability |
HRV for 5 minutes: will be performed for patients undergoing RFA (just before RFA in Operation theatre) and after RFA at the follow up visit (4-6 weeks later) |
| Intervention |
Richards-Campbell Sleep Questionnaire |
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 each assessment.
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Brain activity and functional connectivity networks at resting state. |
At visit to pain clinic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
1. At OPD visit to pain clinic
2, 3 and 4: Before RFA and 4-6 weeks after RFA
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
For the primary objective of the study, the baseline fNIRS of healthy volunteers and patients with TN having NRS/BNI > 4 will be compared at rest. While recording fNIRS in patients with TN, spontaneous pain may get elicited due to touching the face or by talking or cold breeze. We will record this data as fNIRS during pain. Over a period of time, with disease progression, these patients may require intervention in the form of RFA. We will perform fNIRS for these patients after RFA when they come for follow up. Prior to RFA, a 5-minute recording of HRV will be performed at resting condition. HRV will be repeated post-RFA when patients come for follow up. The QOL, sleep and HADS will be assessed at the same time points as HRV. Data Collection (from medical records): Demographics: Age and gender. History: duration of TN, distribution of pain, side affected, description of the type of pain, number of episodes of pain/day, BNI score, NRS score, medications received by the patients, any history of autonomic symptoms (sweating, diarrhea/constipation, tearing in the eyes etc.), triggers of pain Before and after RFA (i.e., 4-6 weeks after RFA): Assessment of QoL using European Quality of Life – 5D-5L dimension scale Assessment of sleep quality using Sleep using Richards-Campbell Sleep Questionnaire Assessment of anxiety and depression using HADS MRI findings
|