Randomized control clinical trial to assess the effect of meditation on selected clinical outcomes in patients with Parkinson’s disease and epilepsy.
- Conditions
- Parkinson's disease and Epilepsy
- Registration Number
- SLCTR/2022/014
- Lead Sponsor
- World Bank, AHEAD 81 grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- Not specified
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In Parkinson's disease group<br>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 ]<br>In epilepsy group<br>Effects on seizures (frequency and duration) using a self-reported seizure diary <br> [Baseline, 4 weeks of commencing intervention, 8 weeks of intervention]<br>
- Secondary Outcome Measures
Name Time Method In Parkinson's disease group<br>1. Change in mean scores on cognition (using SCOPA-COG scale)<br>2. Change in mean scores on quality of life (using questionnaire, PDQ-39) <br>3. Change in mean scores of gait assessment using TUG (time up and go) test.<br>between both groups. [Baseline, 4 weeks of commencing intervention, 8 weeks of intervention]<br>In epilepsy group<br>1. Percentage distribution of EEG wave form frequencies in different scalp regions would be compared between the 2 groups<br>2. Change in mean scores in cognition using RBANS questionnaire between groups.<br>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]<br>