A study of Gut-Brain axis by brain stimulation and probiotics in Parkinson disease.
Not Applicable
- Conditions
- Health Condition 1: G20- Parkinsons disease
- Registration Number
- CTRI/2022/09/045759
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>excitability parameters, Electrogastrography Assessment) will be recorded at Baseline (immediately after recruitment) <br/ ><br>2. After 12 weeks of probiotic supplementation, MDS-UPDRS, corticomotor <br/ ><br>excitability parameters, Electrogastrography Assessment will be done. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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. <br/ ><br>2. At the end of 12 weeks, post intervention assessment of all above mentioned parameters and assessment will be done.