Home » Trials » SLCTR/2022/014
Randomized control clinical trial to assess the effect of meditation on selected clinical outcomes in patients with Parkinson’s disease and epilepsy
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SLCTR Registration Number
SLCTR/2022/014
Date of Registration
The date of last modification
Feb 02, 2024
Trial Status
Scientific Title of Trial
Randomized control clinical trial to assess the effect of meditation on selected clinical outcomes in patients with Parkinson’s disease and epilepsy
Public Title of Trial
Randomized control clinical trial to assess the effect of meditation on selected clinical outcomes in patients with Parkinson’s disease and epilepsy.
Disease or Health Condition(s) Studied
Parkinson's disease and Epilepsy
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1277-1048
Any other number(s) assigned to the trial and issuing authority
EC-21-141
What is the research question being addressed?
What are the effects of meditation on selected clinical outcomes in patients with Parkinson’s disease and epilepsy?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Other
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
Protocol will include every other week physical (onsite) guided sessions and twice a week online guided sessions conducted by the meditation trainer throughout the period of 8 weeks of intervention. Thus the total number of guided sessions would be 20 out of which 4 sessions will be attended physically while the remaining 16 sessions would be attended virtually. Each guided session will have a duration of a minimum of 40 mins. Participants are expected to attend daily self-practice meditation sessions for 40 mins as instructed by the trainer who is an experienced trainer in meditation. This duration will be monitored though a self maintained daily log. .
Once the participants are selected both the participants and the accompanying care givers would be trained by the PI on using the online platforms (Zoom platform) for online training sessions based on the devices at hand.
Setting: In the event where the participants do not have the facility for online technology, it will be made available at the RPFC, Faculty of Medicine, University of Colombo. Participants may physically attend this venue and attend the online sessions through the computers provided at the venue. Site -Onsite training will be conducted at a hall at the Clinical Medicine Academic Research Centre (CLINMARC) at the National Hospital of Sri Lanka (NHSL).
Randomization and Controls: Simple random sampling would be the method of randomization in this study. Controls will continue with their usual prescribed medicines during the 8-week period of intervention. The controls would be wait listed for the intervention at the end of 8 weeks.
Inclusion criteria
Inclusion criteria for Parkinson’s disease group
1) Diagnosis of PD according to Movement Disorder Society clinical diagnostic criteria for Parkinson Disease 2) Patients in Hoehn and Yahr stages I–III 3) Optimally treated with PD medication and unlikely to require anti-PD medication adjustments in the next one month 4) Stable dose of all medications for 30 days prior to inclusion 5) Lack of cognitive dysfunction as evidenced by the Montreal Cognitive Assessment Test (MoCA) (score greater than or equal to 26) 6) No known unstable or life-threatening concomitant disease 7) No previous meditation training and or regular practice 8) Commitment to attend meditation training sessions both onsite and online and to perform the prescribed daily homework of meditation.
Inclusion criteria for Epilepsy group
1) Patients aged 18 years or older 2) Having a clinical diagnosis of medication-resistant epilepsy 3) Seizure frequency of 4 or more seizures per month 4) On a stable antiepileptic drug regimen for the prior ?30 days 5) No history of status epilepticus within the previous 6 months 6) Not pregnant or planning pregnancy 7) Able to maintain a seizure diary independently 8) No known unstable or life-threatening concomitant disease 9) No previous meditation training or regular practice 10) Commitment to attend meditation training sessions both onsite and online and to perform the prescribed daily homework of meditation
Exclusion criteria
Exclusion criteria for Parkinson disease group
1) Usage of neuroleptics or other drugs that induce parkinsonism within 60 days prior to inclusion 2) Patients with psychotic symptoms 3) Atypical parkinsonian syndromes
Exclusion criteria for Epilepsy group
1.) Patients with coexisting psychiatric diagnosis
2.) Patients with intellectual impairment
3.) Alcohol or substance dependence
Primary outcome(s)
1.
In Parkinson's disease group Change in mean motor scores (using SPES/SCOPA – Motor scale) and non motor scores (using SENS-PD scale) between groups |
[ Baseline, 4 weeks of commencing intervention, 8 weeks of intervention ] |
2.
In epilepsy group Effects on seizures (frequency and duration) using a self-reported seizure diary |
[ Baseline, 4 weeks of commencing intervention, 8 weeks of intervention ] |
Secondary outcome(s)
1.
In Parkinson's disease group 1. Change in mean scores on cognition (using SCOPA-COG scale) 2. Change in mean scores on quality of life (using questionnaire, PDQ-39) 3. Change in mean scores of gait assessment using TUG (time up and go) test. between both groups. |
[ Baseline, 4 weeks of commencing intervention, 8 weeks of intervention ] |
2.
In epilepsy group 1. Percentage distribution of EEG wave form frequencies in different scalp regions would be compared between the 2 groups 2. Change in mean scores in cognition using RBANS questionnaire between groups. 3. Change in mean scores in quality of life using QUOLIE-31 questionnaire between groups. |
[ Baseline, 4 weeks of commencing intervention, 8 weeks of intervention ] |
Target number/sample size
100 (50 for each disorder with 25 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2022-06-15
Anticipated end date
2022-12-31
Date of first enrollment
2022-07-01
Date of study completion
2023-03-29
Recruitment status
Complete: follow up complete
Funding source
AHEAD 81
Regulatory approvals
N/A
Status
Approved
Date of Approval
2022-03-26
Approval number
EC-21-141
Details of Ethics Review Committee
Name: | Ethics Review Committee of the Faculty of Medicine, University of Colombo |
Institutional Address: | Ethics Review Committee Faculty of Medicine University of Colombo P O Box 271, Kynsey Road, Colombo 8, Sri Lanka |
Telephone: | +94-11-2695300 ext 240 |
Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Kumarangie Vithanage
Senior Lecturer and Consultant Neurologist
Department of Physiology
Faculty of Medicine
University of Colombo
0112695300
0772988849
kumarangie@physiol.cmb.ac.lk
Contact Person for Public Queries
Kumarangie Vithanage
Senior Lecturer and Consultant Neurologist
Department of Physiology
Faculty of Medicine
University of Colombo
0112695300
0772988849
kumarangie@physiol.cmb.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant data that underlie the results being reported, will be shared after de-identification (text, tables, figures and appendices). The study protocol will also be shared. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, including for individual participant data meta analysis. Proposals should be directed to kumarangie@physiol.cmb.ac.lk. To gain access, data requestors will need to sign a data access agreement.
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
2023-03-29
Final sample size
Date of first publication
Link to results
Brief summary of results