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

08 Aug 2022

The date of last modification

Apr 11, 2023



Application Summary


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)


Trial Details


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

  1. All patients (males and females) with a confirmed diagnosis of TLE and HS aged 18 – 60 years with cognitive impairment detected at baseline of the study
  2. Subjects who have access to a smart phone of any kind and can operate the phone.

Exclusion criteria

  1. Patients with active psychotic and mood symptoms assessed through the Short General Health Questionnaire (GHQ-12)
  2. Patients having delirium/ acute confusion resulting from a recent acute event including seizures.
  3. IQ below 70. This will be assessed using Test of Nonverbal Intelligence (TONI-3) study instrument.
  4. Patients with an existing diagnosis of learning disability
  5. Patients with established cognitive impairment due to other causes than TLE
  6. Patients with hearing and visual impairment compromising the ability to coorporate with the tests and the intervention
  7. Presence of another neurological disorder (e.g. dementia, stroke, epilepsy, and traumatic brain injury resulting in a loss of consciousness for more than 30 minutes)
  8. Patients with a history of photosensitive seizures
  9. Patients who are undergoing/have similar intervention/s currently or in the recent past
  10. Patients who are undergoing treatment changes or have planned changes to the treatment in the next six months
  11. Patients who develop lack of capacity to continue during the study period.


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.
  1. Improvement in quality of life: This will be assessed using WHOQOL-BREF instrument.

  2. Intelligence: This will be assessed using Test of Nonverbal Intelligence (TONI-3) study instrument

  3. Psychological status: This will be assessed using General Health Questionnaire-12 (GHQ-12)

[

[ 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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization







Secondary study sponsor (If any)







Trial Completion details


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