| 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
|
|
|
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
|
|
|
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. |