| CTRI Number |
CTRI/2022/09/045759 [Registered on: 21/09/2022] Trial Registered Prospectively |
| Last Modified On: |
31/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Other (Specify) [Transcranial magnetic stimulation] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study of Gut-Brain axis by brain stimulation and probiotics in Parkinson disease. |
|
Scientific Title of Study
|
To investigate the combined neuromodulatory effects of intermittent theta burst stimulation (iTBS) and probiotics on gut-brain axis in Parkinson’s disease – a randomized controlled trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUMAN JAIN |
| Designation |
PROFESSOR |
| Affiliation |
All India Institute of Medical Sciecnes |
| Address |
2020, Department of Physiology, AIIMS
Ansari nagar
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
sumanjain10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reena Chittora |
| Designation |
Research Associate |
| Affiliation |
All India Institute of Medical Sciecnes |
| Address |
2018, Department of Physiology, AIIMS
Dept. of Physiology, AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
reenachittora89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reena Chittora |
| Designation |
Research Associate |
| Affiliation |
All India Institute of Medical Sciecnes |
| Address |
2018, Department of Physiology, AIIMS
Dept. of Physiology, AIIMS, Ansari Nagar
West
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
reenachittora89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian council of medical research, New Delhi |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Indian council of medical research, new Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suman Jain |
AIIMS |
2001A, Brain stimulation and modulation lab, Dept. of Physiology
South
DELHI |
09810763285
sumanjain10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Probiotics |
Probiotics sachet will be given orally once in a Day for 12 weeks |
| Intervention |
TRANSCRANIAL MAGNETIC STIMULATION |
Single session of Non-invasive intermittent theta burst stimulation will be given at motor cortex at 50Hz frequency, total 600 pulses will be given in 3 min. |
| Intervention |
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 will be given in 3 min. with Probiotics sachet will be given orally once in a Day for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients should be on stable diet and any other intervention/ new drug must not be started at least one month prior to the recruitment |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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.
2. At the end of 12 weeks, post intervention assessment of all above mentioned parameters and assessment will be done. |
|
|
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)
|
15/10/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet and will publish after completion of the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |