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

Recruiting

• Conditions: Parkinsons disease,

• Registration Number: CTRI/2022/09/045759
• Lead Sponsor: ICMR

Brief Summary

Parkinson’s disease (PD) is a progressive neurodegenerative disease characterized by the loss of dopamine neurons in the substantia nigra pars compacta. Gastrointestinal (GI) dysfunction is one of the most common non-motor symptoms of Parkinson’s disease. Abnormal gastric motility and delayed gastric emptying occur in early-stage PD even prior to pharmacological treatment, which is attributed to alterations in gut microbiota.  Neurogenic orthostatic hypotension (nOH), is a potentially serious manifestation of cardiovascular sympathetic failure that occurs in approximately 30% of patients with PD. Recently, transcranial magnetic stimulation (TMS) has been used extensively to modulate the cortical plasticity via non-invasive magnetic stimulation applied to the motor cortex. Evidence suggests probiotics may decrease pro-inflammatory cytokines, oxidative stress, and potentially pathogenic bacterial overgrowth in patients with PD. The present study is designed to unravel the therapeutic role of single-session (excitatory) intermittent theta burst stimulation (iTBS) of motor cortex along with probiotics on gut brain axis and neurogenic orthostatic hypotension in PD patients. A Battery of questionnaires, blood pressure assessment, electrogastrography (EGG), cortical excitability will be recorded and correlated with the motor cortex excitability of the PD patients. Thus, the present study will be helpful in mitigating the disease complexity of PD by the novel, non-invasive combinatorial strategy over classical pharmacological based approaches.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-08-31
• Study Start: 2022-10-15

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

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

• Use of vasoconstriction agents or long-acting antihypertensive medications.
• Other causes of neurogenic orthostatic hypotension except Parkinson disease.
• Presence of any metal implant.
• 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.	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 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.	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.

Trial Locations

Locations (1)

AIIMS; 🇮🇳 South, DELHI, India

AIIMS

🇮🇳South, DELHI, India

Dr Suman Jain

Principal investigator

09810763285

sumanjain10@gmail.com