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CTRI Number  CTRI/2024/09/074151 [Registered on: 23/09/2024] Trial Registered Prospectively
Last Modified On: 12/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Transcranial Magnetic Stimulation in treating Metabolic Syndrome- Single Bling Randomised control trial 
Scientific Title of Study   Role of Repetitive Transcranial Magnetic Stimulation in treating Metabolic Syndrome 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohd Zaki Siddiqui 
Designation  Associate professor Department of Medicine 
Affiliation  MLB Medical college and associated hospital 
Address  Room No.138,Department of Medicine Division- Neurology MLB Medical college and associated hospital kanpur road

Jhansi
UTTAR PRADESH
284128
India 
Phone  9450137367  
Fax  00  
Email  drzakisiddiqui@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swarna Tripathi 
Designation  Junior Resident Department of Medicine 
Affiliation  MLB Medical college and associated hospital 
Address  Room no. 138 Department of Medicine MLB Medical college and associated hospital kanpur road

Jhansi
UTTAR PRADESH
284128
India 
Phone  7275072716  
Fax  00  
Email  swarnatripathikk27@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohd Zaki Siddiqui 
Designation  Associate professor Department of Medicine 
Affiliation  MLB Medical college and associated hospital 
Address  Room No. 138 Department of Medicine MLB Medical college and associated hospital kanpur road

Jhansi
UTTAR PRADESH
284128
India 
Phone  9450137367  
Fax  00  
Email  drzakisiddiqui@gmail.com  
 
Source of Monetary or Material Support  
MLB Medical college,Kanpurroad,Jhansi 284128 Uttar Pradesh INDIA 
 
Primary Sponsor  
Name  MLB Medical college 
Address  Kanpur Road,Jhansi 284128 Uttar Pradesh INDIA 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohd Zaki Siddiqui  MLB Medical college and associated hospital  Room no 138 Department of Medicine Division-Neurology
Jhansi
UTTAR PRADESH 
09450137367
00
drzakisiddiqui@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethicscommitteemlbmedicalcollegemlbmedicalcollegeAEthicsCommitteeMLBMedicalCollegeMLBMedicalCollegeAndAssociatedHospitalndAssociatedHospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E889||Metabolic disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  rTMS PROTOCOL  Repetitive transcranial magnetic stimulation can be performed as an outpatient procedure. Transcranial magnetic stimulation is a unique stimulation protocol that has been used for both diagnostic and therapeutic purposes. A total of 12 Sessions,3 Sessions per week for 4 weeksrTMS being delivered to the left DLPFC 
Comparator Agent  ShamTMS  Sham transcranial magnetic stimulation (TMS) is designed to mimic the look, sound, and feel of real TMS, but without creating a significant magnetic field. The sham coil has a similar appearance, sound, and usage to the real coil, but with a reduced electric field thats close to zero in the brain. The sham treatment protocol is also consistent with the active treatment, including the number of pulses, frequency, and duration. Total 12 sessions,3 sessions per week for 4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Agemorethan18 years
2.NCEP ATP III (any 3 or more of 5) criteria for metabolic syndrome:
a)Central obesity:greaterthanorequalto108 cm (Male),greaterthanorequalto 88 cm (Female)
b)Hypertriglyceridemia: Triglycerides greaterthanorequalto 150mg/dl or specific medication
c)Low HDL cholesterol:lessthanorequalto 40mg/dl (Male) and lessthanorequalto 50mg/dl (Female) or specific medication.
d)Hypertension: Blood pressure greaterthanorequalto 130 mm Hg systolic or greaterthanorequalto 85 mm Hg diastolic or specific medication.
e)Fasting plasma glucose greaterthanorequalto 100mg/dl or specific medication or previously diagnosed type 2 diabetes.
3.Ability to follow verbal or written instructions.


 
 
ExclusionCriteria 
Details  1.Axis-I and II psychiatric disorders according to DSM criteria 5 (such as Major Depression, Bipolar Disorder, or Attention Deficit Disorder)
2.IQ score less than 85
3.Organic brain disorders: history of stroke, brain major surgery or head trauma.
4.Pregnancy or lactation, absence of medically approved contraceptive methods in females of childbearing potential.
5.Serious or poorly controlled diseases (hepatic, renal or heart failure, atrial fibrillation or other heart rhythm disorders, uncontrolled diabetes).
6.History of any drug addiction, substance abuse or alcoholism.
7.Metal in any part of the head or body (implanted infusion pumps, intracardiac devices like pacemaker, heart valves) except dental fillings.
8.History of epilepsy or a family history of epilepsy among first-degree relatives.
9.Medications associatedwith lowered seizure threshold (such as antidepressants, anxiolytics…)
10.Recent use of anti-obesity medications or very-low-calorie diet (within 3 months prior to therapy or at any time during data collection).
11.Patients affected by galactosemia, priapism and terminal illness. Patients on fluid restriction for SIADH or other conditions.
12.Contraindications to perform the Magnetic Resonance Imaging (MRI).
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Weight change in kilograms.
2.Changes in food craving levels.
 
Immediately after completing 12 sessions of intervention.
Then at interval of 15 days,1 month and 3 months.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Changes in Random Blood Glucose levels.
2.Changes in Glycated Haemoglobin levels.
3.Changes in Cholesterol levels.
4.Changes in Triglyceride levels.
5.Changes in high sensitivity C-reactive protein levels.
6.Changes in Cortisol levels.
 
Total Duration of study is 120 days from start of therapy after screening 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   25/09/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The metabolic syndrome, which covers a wide variety of pathological concerns, is rapidly becoming a global pandemic.

The metabolic syndrome (syndrome X, insulin resistance syndrome) consists of a constellation of metabolic abnormalities that confer increased risk of cardiovascular disease (CVD). Metabolic syndrome is defined as the occurrence of three abnormal results out of five components: elevated waist circumference, elevated triglycerides, reduced high density lipoprotein cholesterol, elevated blood pressure, and elevated fasting plasma glucose.

Current therapeutic options for metabolic syndrome are limited to individual treatment for hypertension, hyperglycemia and hypertriglyceridemia, as well as dietary control measures and regular exercise, including water-based training.

Repetitive transcranial magnetic stimulation (rTMS) is a safe and non-invasive neuromodulation technique that may reduce the food craving levels in obese patients by changing cortical brain activity. TMS alone or in combination with other anti-obesity approaches may open new ways to sustain the efficacy of weight control interventions.

As part of this pilot study, the parameters like weight change, changes in food craving levels, and cardiometabolic risk factors like fasting lipid levels, total cholesterol, high-density lipoproteins, low-density lipoproteins, fasting glucose levels and high sensitivity C- reactive protein, along with food craving questionnaires will be measured at the end of the therapy and on three follow up visits at the end of fifteen days, one month and three months after the end of the therapy.

 
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