Effect of therapeutic nerve stimulation in Parkinson’s Disease

Optimising Percutaneous Trigeminal and Vagal Intermittent Electro-Therapeutic Nerve Stimulation in Parkinson’s Disease (OPTIoNS-PD) - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066253

Enrollment

Registered

2024-04-24

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: G20- Parkinsons disease

Interventions

Intervention1: Transauricular Vagus Nerve Stimulation (tVNS) and Trigeminal Nerve Stimulation (TNS): Portable Transcutaneous Electrical Stimulation Device programmed for tVNS and TNS Active stimulatio

Eligibility

Inclusion criteria

Inclusion criteria: Consenting diagnosed case of Parkinsons Disease as per UK Brain Bank Criteria (40-80 years).

Exclusion criteria

Exclusion criteria: Seizure history History of any other neurological diseases or severe systemic diseases. Diseases which are likely to increase the systemic inflammation. Those with a contraindication for TMS such as metallic implants or implanted permanent pacemaker were excluded.

Design outcomes

Primary

Measure	Time frame
Clinical outcome measurement 1.Motor and non-motor analysis with MDS UPDRS: MDS-UPDRS is the most widely used clinical scale for assessing overall motor and non-motor function/dysfunction and disease severity in patients with Parkinson’s disease. 2.Objective gait assessment: Spatial and temporal gait parameters will be assessed using electronic walkway (GAITRite©). It is a 6 meters long mat embedded with a grid of pressure sensors. It is connected to a computer for gait data acquisition through a software. 3.Assessment of falls using the Falls Efficacy Scale-International (FES-I) questionnaire 4.Assessment of cognitive function with MMSE and Mattis DRS 5.Assessment of Rapid Eye Movement Sleep Behaviour Disorder using a validated questionnaire (RBDSQ)Timepoint: Day 0, Week 4, week 6, Week 10	—

Measure

Time frame

Clinical outcome measurement 1.Motor and non-motor analysis with MDS UPDRS: MDS-UPDRS is the most widely used clinical scale for assessing overall motor and non-motor function/dysfunction and disease severity in patients with Parkinson’s disease. 2.Objective gait assessment: Spatial and temporal gait parameters will be assessed using electronic walkway (GAITRite©). It is a 6 meters long mat embedded with a grid of pressure sensors. It is connected to a computer for gait data acquisition through a software. 3.Assessment of falls using the Falls Efficacy Scale-International (FES-I) questionnaire 4.Assessment of cognitive function with MMSE and Mattis DRS 5.Assessment of Rapid Eye Movement Sleep Behaviour Disorder using a validated questionnaire (RBDSQ)Timepoint: Day 0, Week 4, week 6, Week 10

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Secondary

Measure	Time frame
Serum biomarker estimation (on PD patients) 1.Inflammatory profile and Brain derived neurotrophic factor (BDNF): Serum levels of IL-6, TNF Alpha, IL-10, BDNF (pg/ml) will be tested using ELISA Kit and analysed using Microplate Reader. 2.Determination of reduced glutathione (GSH) content and superoxide dismutase (SOD) activity will be estimated using spectrophotometerTimepoint: Day 0, Week 4, week 6, Week 10	—

Measure

Time frame

Serum biomarker estimation (on PD patients) 1.Inflammatory profile and Brain derived neurotrophic factor (BDNF): Serum levels of IL-6, TNF Alpha, IL-10, BDNF (pg/ml) will be tested using ELISA Kit and analysed using Microplate Reader. 2.Determination of reduced glutathione (GSH) content and superoxide dismutase (SOD) activity will be estimated using spectrophotometerTimepoint: Day 0, Week 4, week 6, Week 10

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Countries

India

Contacts

Public ContactDr Supriyo Choudhury

Institute of Neurosciences, Kolkata

choudhurydrsupriyo@gmail.com9433106238

Outcome results

None listed

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