| CTRI Number |
CTRI/2019/10/021800 [Registered on: 25/10/2019] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study to Test Effectiveness of COSMA Gaming Software on Dementia Patients |
|
Scientific Title of Study
|
An Open Label, Prospective, Randomised, Comparative, Two Arm Clinical Study to Evaluate the Effectiveness of Gaming Platform – COSMA Software from Cerebrum Matter Ltd. in Adults with Mild NeuroCognitive Impairment, Vascular Dementia and/or Dementia Associated with Alzheimer’s Disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/PSY/051/19 Version No: 02 Dated: 19-Aug-19 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VTSriraam |
| Designation |
Chief Medical Research Coordinator |
| Affiliation |
Aurous HealthCare Research and Development India Private Limited |
| Address |
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam,
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VTSriraam |
| Designation |
Chief Medical Research Coordinator |
| Affiliation |
Aurous HealthCare Research and Development India Private Limited |
| Address |
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam,
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VTSriraam |
| Designation |
Chief Medical Research Coordinator |
| Affiliation |
Aurous HealthCare Research and Development India Private Limited |
| Address |
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam,
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| Ms. Kartheka Bojan
Cerebrum Matter Limited
5, Oakwood drive, ATIC Building
Loughborough, England LE11 3QF |
|
|
Primary Sponsor
|
| Name |
Cerebrum Matter Limited |
| Address |
5, Oakwood drive, ATIC Building
Loughborough, England LE11 3QF |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024. |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gopukumar Kumarpillai |
Bangalore Neuro Centre |
Room No 1, Department of Neurology
10th Cross , Margosa Road,
Malleswaram, Bangalore-560 003
Bangalore
KARNATAKA |
8762687741
gopukumar@yahoo.com |
| Dr VS Natarajan |
Memory Clinic |
Room No 1, Old No.18 A, New No. 50, Flowers Road,
Kilpauk, Chennai – 600 010.
Chennai
TAMIL NADU |
9500078740
dr_v_s_natarajan@yahoo.com |
| Dr VT Sriraam MBBS MD |
Raam Clinic |
Room No 7, Department of General Health,
#180/109, G1 &G2, RR Villa, Rangarajapuram Main Road,
Kodambakkam, Chennai – 600024
Chennai
TAMIL NADU |
9840909155
md@auroushealthcare.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Clinicom Independent EC for Evaluation of Protocols for Clinical Research |
Approved |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G300||Alzheimers disease with early onset, (2) ICD-10 Condition: F015||Vascular dementia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gaming Platform - COSMA Software from Cerebrum Matter Ltd |
40 Subjects who are randomised into the COSMA Treatment arm will pay the COSMA games on a tablet once a day, everyday for 28 days |
| Comparator Agent |
Not Applicable |
20 Subjects who are randomised into the CONTROL Treatment arm will not play any games everyday.
They will play COSMA games only when they visit the hospital on Day 1, Day 14 and Day 28 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Verified neurological evaluation and diagnosis of Mild NeuroCognitive Impairment, Vascular Dementia and/or Dementia associated with Alzheimer’s Disease
2. Neurocognitive evaluation with Functional Assessment Staging Test : Stage 3 to Stage 5
3. Male and female adults less than 65 years of age
4. Subjects who are classified as right handed
5. Subjects who can read and write Tamil and/or English
6. Subjects who can use the provided Android Tablet
7. Subjects with a dedicated LAR or caretaker to address any study objectives in lieu of the subject.
8. Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with mental illness and/or neuropsychiatric disorders.
2. Subjects who are on anti-depressants, anti-psychotics and/or medication that may cause worsening in cognitive functions.
3. Subjects with significant primary visual impairments.
4. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
5. Subjects who have participated in any clinical study within 3 months from the date of enrolment.
6. Females who are pregnant or lactating or planning to become pregnant or unwilling to use double barrier method during the study period.
7. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
8. Subjects, who in the opinion of the Investigator/CRMC are not eligible for enrolment in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Apathy Evaluation Scale: Reduction of ≥10 scores
2. Trail Marking Test A: Improvement of ≥5 sec
3. Trail Marking Test B : Improvement ≥ 10 sec
4. Clinical Global Impression: Score of ≤3
5. 32 channel EEG:
i. Increase in Alpha and Beta Waves
ii. Different brain region activation, shift.
6. CANTAB – Increase of  3 Scores
7. COSMA Games
i. Time Taken : ≥25% reduction.
ii. No of attempts: ≥25% reduction.
iii. No of correct answers: ≥25% improvement |
Apathy Evaluation Scale : Day 1, Day 14, Day 28
Trail Marking Test A : Day 1, Day 14, Day 28
Trail Marking Test B : Day 1, Day 14, Day 28
Clinical Global Impression : Day 28
32 Channel EEG : Day 1, Day 14, Day 28
CANTAB : Day 1, Day 14, Day 28
COSMA GAMES : Day 1, Day 14, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/11/2019 |
| Date of Study Completion (India) |
03/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Study Design : An Open Label, Prospective, Randomised, Comparative, Two Arm Clinical Study Indication: Mild NeuroCognitive Impairment, Vascular Dementia and/or Dementia associated with Alzheimer’s Disease Subject Population: 60 Subjects - Male and female adults less than 65 years of age diagnosed with Mild NeuroCognitive Impairment, Vascular Dementia and/or Dementia associated with Alzheimer’s Disease (Stage 3 to Stage 5 as per Functional Assessment Staging Test) Investigational Device : Gaming Platform : COSMA Software from Cerebrum Matter Ltd. Treatment Arms : - Treatment Arm I : COSMA Players : 40 Subjects who play the games everyday for 28 days. - Treatment Arm II : Control Players : 20 Subjects who will play the games only for 3 days (Day 1, Day 14, Day 28) Assessments: 1. Edinburgh Handedness Questionnaire : Screening 2. MRI for Diagnosis : Screening 3. FAST : Screening 4. COSMA Games + 32 Channel EEG : Day 1. Day 14, Day 28 5. CANTAB : Day 1. Day 14, Day 28 6. Apathy Evaluation Scale : Day 1. Day 14, Day 28 7. Trail Marking Test A & B : Day 1. Day 14, Day 28 8. Clinical Global Impression Scale : Day 28 9. COSMA Usability Feedback Form : Day 28 Results
Digital Therapy with COSMA for the minimum of 28 days, has helped
Subjects with MCI greatly in improving their sense of apathy and combat loss of
interest. With COSMA, Subjects with MCI were able to
reduce the time taken for Trail Marking Test : A from 4 minutes 12 seconds to 2
minutes 20 seconds in just 28 days.
There was no improvement seen in the subjects who acted as Control. This amounts to an improvement of 46.48% in
Trail Marking Test A with 28 days of COSMA. With COSMA, Subjects with MCI were able to
reduce the time taken for Trail Marking Test : B from 4 minutes 57 seconds to 3
minutes 33 seconds in just 28 days.
There was no improvement seen in the subjects who acted as Control. This amounts to an improvement of 35.96% in
Trail Marking Test B with 28 days of COSMA. After 28 days of COSMA, the Clinician assessed
the MCI patients to be “much improved†compared to baseline, while subjects
deemed controlled were assessed to be minimally worse. |