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

10 Jun 2022

The date of last modification

Jun 10, 2022



Application Summary


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


Trial Details


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

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Baseline, 4 weeks of commencing intervention, 8 weeks of intervention

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2.

In epilepsy group Effects on seizures (frequency and duration) using a self-reported seizure diary

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Baseline, 4 weeks of commencing intervention, 8 weeks of intervention

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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.

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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.

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Baseline, 4 weeks of commencing intervention, 8 weeks of intervention

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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


Date of study completion


Recruitment status

Pending


Funding source

AHEAD 81


Regulatory approvals

N/A



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

World Bank, AHEAD 81 grant

79/1, 5th Lane, Colombo 03



Secondary study sponsor (If any)







Trial Completion details


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


Final sample size


Date of first publication


Link to results


Brief summary of results