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A study of Gut-Brain axis by brain stimulation and probiotics in Parkinson disease.

To investigate the combined neuromodulatory effects of intermittent theta burst stimulation (iTBS) and probiotics on gut-brain axis in Parkinsonââ?¬â?¢s disease ââ?¬â?? a randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045759
Enrollment
60
Registered
2022-09-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: TRANSCRANIAL MAGNETIC STIMULATION and PROBIOTICS: Single session of Non-invasive intermittent theta burst stimulation will be given at motor cortex at 50Hz frequency, total 600 pulses w

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients should be on stable diet and any other intervention/ new drug must not be started at least one month prior to the recruitment

Exclusion criteria

Exclusion criteria: 1. Use of vasoconstriction agents or long-acting antihypertensive medications. 2. Other causes of neurogenic orthostatic hypotension except Parkinson disease. 3. Presence of any metal implant. 4. History of seizure and other severe mental illness.

Design outcomes

Primary

MeasureTime frame
After 12 weeks Intermittent theta burst stimulation and probiotics will improve motor symptoms and neural plasticity along with changes in gut-brain axis in PD Patients.Timepoint: 1. All scales and Parameters (MDS-UPDRS, corticomotor excitability parameters, Electrogastrography Assessment) will be recorded at Baseline (immediately after recruitment) 2. After 12 weeks of probiotic supplementation, MDS-UPDRS, corticomotor excitability parameters, Electrogastrography Assessment will be done.—

Secondary

MeasureTime frame
The combinatorial therapeutic strategy of probiotics along with intermittent theta bust stimulation will be able to restore the non-motor and autonomic nervous system functions in PD patients.Timepoint: 1. Base line assessment (after recruitment) of Orthostatic hypotension questionnaire: Orthostatic hypotension symptom assessment (OHSA) and Orthostatic hypotension daily activity scale (OHDAS), Supine, sitting and standing blood pressure assessment will be done. 2. At the end of 12 weeks, post intervention assessment of all above mentioned parameters and assessment will be done.—

Countries

India

Contacts

Public ContactReena Chittora

All India Institute of Medical Sciecnes

reenachittora89@gmail.com

Outcome results

None listed

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