What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include levodopa, dopamine agonists, cholinesterase inhibitors, and melatonin. Levodopa can cause nausea, somnolence, dizziness, headache, confusion, hallucinations, delusions, agitation, psychosis, and orthostatic hypotension. Dopamine agonists may lead to compulsive behaviors, confusion, and hallucinations. Cholinesterase inhibitors, such as rivastigmine and donepezil, can cause worsened tremor, nausea, and vomiting. Melatonin is generally well-tolerated but may cause mild side effects like drowsiness and dizziness.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Parkinson's Disease. These include VMAT2 inhibitors like tetrabenazine, deutetrabenazine, and valbenazine, which are primarily used for managing chorea and tardive dyskinesia. Dopamine agonists such as pramipexole, ropinirole, and transdermal rotigotine are also widely used, either as monotherapy or in combination with levodopa, to manage motor symptoms. Levodopa remains a cornerstone of PD treatment, often combined with carbidopa to enhance its efficacy and reduce side effects. Additionally, MAO B inhibitors and amantadine are used to augment the benefits of levodopa and manage specific symptoms like tremor.

What other types of research exist?

Promising novel alternatives for Parkinson's Disease treatment in 2024 include continuous drug delivery systems aimed at providing sustained benefits and minimizing side effects, and nondopaminergic pharmacological therapies targeting motor features of PD. These approaches are under development and may offer new avenues for managing PD symptoms more effectively.

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Yoga for Mental Health in Parkinson's Disease

N/A

Recruiting

Led By Balachundar Subramaniam, MD, MPH

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age above 18

Diagnosed with Parkinson's Disease

Must not have

Not able to self-consent to participate in the study

Severe stage of PD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for phase 1 analysis: baseline to week 12. for phase 2 analysis: baseline to week 18.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if specific breathing exercises and guided meditations can help people with Parkinson's disease feel less anxious and depressed. The goal is to see if these practices improve mental health and quality of life.

Who is the study for?

This trial is for adults over 18 in the US with Parkinson's Disease who are interested in a Breath, Sound, and Meditation Webinar. They must have mild to moderate symptoms (PAS score ≥12), be able to read English, and participate physically and mentally. Those with severe PD or conditions like major depression under medication, schizophrenia, or bipolar disorder cannot join.

What is being tested?

The study tests if yoga practices like Isha Kriya, Nadi Shuddhi, and Nada Yoga improve mental health in Parkinson's patients compared to routine activities. Participants will be randomly assigned to either the yoga group or control group and followed up at four intervals over 24 weeks.

What are the potential side effects?

Yoga interventions typically have minimal side effects but may include muscle soreness or strain. Since this involves gentle breathwork and meditation techniques, risks are considered low; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I have been diagnosed with Parkinson's Disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give consent for myself to join the study.

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My Parkinson's disease is in a severe stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for phase 1 analysis: baseline to week 12. for phase 2 analysis: baseline to week 18.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for phase 1 analysis: baseline to week 12. for phase 2 analysis: baseline to week 18.

This trial's timeline: 3 weeks for screening, Varies for treatment, and for phase 1 analysis: baseline to week 12. for phase 2 analysis: baseline to week 18. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Anxiety

Change in Compliance

Secondary study objectives

Change in GRID-Hamilton Depression Scale (HAMD)

Change in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Change in Perceived Stress Scale (PSS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment3 Interventions

Breathing and Wellness Webinar: a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga).

Group II: Waitlisted Control GroupActive Control1 Intervention

This group will be asked to wait for 6 weeks before being introduced to the Breathing and Wellness Webinar intervention which includes a Yogic Breathing practice (Nadi Shuddhi) and two guided meditations (Isha Kriya and Nada Yoga).

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The main treatments for Parkinson's Disease (PD) include levodopa, dopamine agonists, MAO-B inhibitors, and amantadine. Levodopa is converted to dopamine in the brain, replenishing the diminished dopamine levels characteristic of PD. Dopamine agonists mimic dopamine by stimulating dopamine receptors directly. MAO-B inhibitors prevent the breakdown of brain dopamine, thereby increasing its availability. Amantadine helps reduce symptoms by promoting dopamine release and blocking glutamate receptors. These treatments are crucial as they address the core issue of dopamine deficiency in PD, thereby improving motor function and quality of life for patients.

Current Management and Emerging Therapies in Multiple System Atrophy.(Neuro)Psychological Interventions for Non-Motor Symptoms in the Treatment of Patients with Parkinson's Disease: a Systematic Umbrella Review.Thalamic noradrenaline in Parkinson's disease: deficits suggest role in motor and non-motor symptoms.