Home » Trials » SLCTR/2022/019
Assessment of prevalence and pattern of cognitive dysfunction in patients with hippocampal sclerosis (HS) and temporal lobe epilepsy (TLE) and the effects of phone aided cognitive rehabilitation (PACR) on patients with cognitive decline due to TLE and HS in a Tertiary Care Hospital in Colombo, Sri Lanka
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SLCTR Registration Number
SLCTR/2022/019
Date of Registration
The date of last modification
Apr 11, 2023
Scientific Title of Trial
Assessment of prevalence and pattern of cognitive dysfunction in patients with hippocampal sclerosis (HS) and temporal lobe epilepsy (TLE) and the effects of phone aided cognitive rehabilitation (PACR) on patients with cognitive decline due to TLE and HS in a Tertiary Care Hospital in Colombo, Sri Lanka
Public Title of Trial
A single arm non randomized study on the effects of phone aided cognitive rehabilitation (PACR) on cognition in patients with cognitive decline due to hippocampal sclerosis (HS) and temporal lobe epilepsy (TLE) at the National Hospital of Sri Lanka
Disease or Health Condition(s) Studied
Temporal lobe epilepsy
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1280-4695
Any other number(s) assigned to the trial and issuing authority
ERC/21 – 030 (SLMA - ERC)
What is the research question being addressed?
How effective is phone aided cognitive rehabilitation (PACR) in improving cognition in patients with cognitive decline due to hippocampal sclerosis (HS) and temporal lobe epilepsy (TLE) at the National Hospital of Sri Lanka?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study setting: National Hospital of Sri Lanka
Method of randomization: none, this is a single arm uncontrolled study.
Intervention: This is a phone aided cognitive rehabilitation (PACR) programme and involves hyper casual mobile phone games which have been developed as a PACR programme to aid neuroplasticity / brain stimulation. The games are formulated in a manner in which with each attempted play the level of difficulty and level of saturation for the game is increased or adjusted based on the capacity of the patient with a view to aid neuroplasticity / brain stimulation.
Two games focused on nonverbal memory (one) and verbal memory (one) will be administered to study participants based on their respective cognitive deficits which are assessed at baseline and will depend on which hemisphere is affected (dominant hemisphere – verbal memory non-dominant hemisphere – non-verbal memory). The games will be administered by a trained psychologist.
During the intervention, all participants will begin the training at the beginner level. Difficulty will increase throughout the intervention period based on their performance. At the end of each training session, game progress will be saved, and participants will begin the next session at that point. Game performance will be recorded for each participant. Moreover, for their training sessions at home, participants will be asked to train at the same time of the day to maintain consistency.
Duration of training time for each participant: 35 minutes p/day for 6 days p/week for a period of 12 weeks (2520mins)
The game performance will be monitored through meta-data accrued during each playtime or event and stored centrally on a remote server.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
Change in mean scores of cognitive functions assessed using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scale. RBANS assesses five domains: immediate and delayed memory, attention, visuospatial construction, and language. |
[ [Baseline, 4 weeks, 8 weeks, 12 weeks and at 6 months from initiating the intervention] ] |
Secondary outcome(s)
1.
|
[ [ Baseline, 4 weeks, 8 weeks, 12 weeks and at 6 months from initiating the intervention] ] |
Target number/sample size
243
Countries of recruitment
Sri Lanka
Anticipated start date
2022-08-08
Anticipated end date
2023-01-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self funded
Regulatory approvals
ERC -SLMA
Status
Approved
Date of Approval
2022-03-05
Approval number
ERC/21-030
Details of Ethics Review Committee
Name: | Ethics Review Committee, Sri Lanka Medical Association |
Institutional Address: | Wijerama House, 06 Wijerama Mawatha, Colombo 00700 |
Telephone: | +94 112 693324 |
Email: | erc.slma@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Kishara Gooneratne
Senior Lecturer
Faculty of Medicine
University of Moratuwa
+94773662903
+94773662903
kishig@gmail.com
Contact Person for Public Queries
Dr Chathurie Suraweera
Senior Lecturer
Faculty of Medicine, University of Colombo
+94773694166
+94773694166
dr.chathurie@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results