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CTRI Number  CTRI/2025/03/081841 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 03/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of electro therapy with brain exercises on the individuals suffering from memory and attention related problems 
Scientific Title of Study   Efficacy of TDCS combined with brain training exercises on various cognitive parameters in Alzheimer Disease: A randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nitesh Sura 
Designation  MPT Student 
Affiliation  Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar

Hisar
HARYANA
125001
India 
Phone  9050526926  
Fax    
Email  Niteshsurajangra03@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manoj Malik 
Designation  Assistant Professor 
Affiliation  Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar

Hisar
HARYANA
125001
India 
Phone  9896221262  
Fax    
Email  Malik_manoj@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Nitesh Sura 
Designation  MPT Student 
Affiliation  Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar

Hisar
HARYANA
125001
India 
Phone  9050526926  
Fax    
Email  Niteshsurajangra03@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana India 125001 
 
Primary Sponsor  
Name  Department of physiotherapy  
Address  Guru Jambheshwar University of Science and Technology Hisar Haryana India 125001 
Type of Sponsor  Research institution 
 
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 Manoj Malik  Guru Jambheshwar University of Science and Technology Hisar, Haryana  Room No. 05 Department of Physiotherapy OPD GJUS&T Hisar, Haryana
Hisar
HARYANA 
09896221262

Malik_manoj@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  TDCS (transcranial direct current stimulation)  Patients in this group with cognitive impairment will be given Transcranial direct current stimulation with cognitive impairment on alternate days for 4 weeks 
Comparator Agent  Transcranial direct current stimulation with Cognitive brain training   Patients in this group with cogntive impairment will be given Transcranial direct current stimulation and Cognitive brain training exercises on alternate days for 4 weeks 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with Alzheimers disease with age group of 50 years or above
Both male and female are included
Patient with Alzheimers disease having cognitive impairments will be included
Patient with Alzheimers disease early stages of dementia
Patients who can easily tolerate the electrical stimulation
Patients who anre able to perform Activities of daily livings without fatigue 
 
ExclusionCriteria 
Details  Uncontrolled medical conditions
cardiovascular disease
Advance or terminal disease or a history of brain neurosurgery
Mental health as History of depression or major depression psychosis or bipolar disorder
Substance use History of alcohol or drug abuse or current or past use of certain medications
Skin or skull abnormalities
Active skin lesions on the scalp or chronic skin problems
Cochlear implants or implanted cranial devices or any stimulators or implants
History of epilepsy, seizures or neurological conditions associated with brain abnormalities except Alzheimers disease
Any history of head injury 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
ADAS  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
MMSE  4 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/03/2025 
Date of Study Completion (India) 21/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="28" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Alzheimer’s disease is a progressive degenerative disease of the brain that gradually deteriorates memory, attention, thinking and reasoning, plaining and performing familiar tasks, decision-making, behavioural patterns, and personality. It also causes abnormal gait patterns and muscular weakness or imbalance. At first, Alzheimer’s disease could only be diagnosed as dementia, a clinical illness marked by significant progressive cognitive impairment across multiple domains or behavioural symptoms severe enough to have a noticeable functional impact on day-to-day functioning. The main characteristic that sets dementia apart from moderate cognitive impairment is the loss of independence experienced by a person who has dementia. Every three seconds, someone in the world gets dementia. In 2020, there will be more than 55 million dementia sufferers worldwide. Every 20 years, this number will nearly double, rising to 78 million in 2030 and 139 million in 2050. Most of the growth will occur in underdeveloped nations. By 2050, 71% of dementia patients would reside in low- and middle-income nations, up from 60% currently. Numerous illnesses and traumas to the brain can lead to dementia. The most prevalent type of dementia, accounting for 60–70% of cases, is Alzheimer disease. One of the main causes of disability and dependency among older adults worldwide, Alzheimer’s disease is currently the seventh greatest cause of death. Globally, there are more than 10 million new cases of dementia annually, or one new case every 3.2 seconds. The abnormal buildup of tau protein tangles inside brain cells and amyloid protein plaques surrounding brain cells is what causes Alzheimer’s disease. Even though the precise cause of this process is unknown, it starts years before any symptoms show up. The synthesis of chemical messengers, or neurotransmitters, is reduced in affected brain cells. involved the passage of neural signals between brain cells. Acetylcholine levels are consistently low in AD patients. The part of the brain that is typically in charge of memories begins to diminish as the brain ages. When the person reaches age 65, the symptoms worsen every five years. Around age 40, 1 in 20 people may have young or early-onset Alzheimer’s. When a large number of their generational family members have dementia at an early age, the individual is at extremely high risk.  A sedentary lifestyle, loneliness or social isolation, untreated depression (although depression can also be a sign of Alzheimer’s disease), and hearing loss are additional risk factors for the condition. Every stage of Alzheimer’s disease begins gradually, with some difficulty performing everyday tasks, and gets worse over time as the stages progress. A degenerative neurological condition, Alzheimer’s disease can lead to several problems, such as: Cognitive challenges: As Alzheimer’s progresses, patients may have memory loss, difficulty paying bills, and difficulty repeating questions. Changes in behaviour: Individuals with Alzheimer’s disease may exhibit pacing, wandering, agitation, and odd behaviours. Depression: Mood swings, sleep issues, and social disengagement are all symptoms of depression, which is prevalent in Alzheimer’s patients. Physical changes: As the illness worsens, bodily abilities including swallowing, balance, and bladder control may be impacted by brain changes. Other health issues including inhaling food or liquid into the lungs, infections like pneumonia, fractures and falls, bedsores, dehydration, and dental issues like mouth sores or tooth rot can result from this. Hallucinations: As Alzheimer’s disease progresses, delusions and hallucinations may manifest. There are various physiotherapy interventions such as strengthening, gait training, coordination training are given to the patient with AD. Currently TDCS (transcranial direct current stimulation) a non-invasive technique is used to improve the memory and cognition. Therefore, the current study is designed to compare the effect of TDCS combined with cognitive brain training exercises and tdcs only.

 
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