| 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
|
|
|
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
|
|
|
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. |