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New treatment option for Transcutaneous Vagal Nerve Stimulation (tVNS)
Official title Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease
ClinicalTrials.gov ID: NCT07588191
What this study is testing
- What it's testing
- This study aims to determine whether electrical stimulation of the ear, when combined with physical and speech therapy, can improve symptoms in subjects diagnosed with Parkinson´s disease, by comparing two different application sites. Each subject will undergo an initial in-person screening and provide consent before participating in the study.
- Time commitment: about 4 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Being a member of the Association or be interested in joining;
- Idiopathic PD diagnosis, stages 2-3 according to the Hoehn \& Yahr scale; confirmed by neurologist
- Ability to walk independently for at least 1 minute ant turn 180° without assistance;
- Exhibiting symptoms of hypokinetic dysarthria;
- On stable dopaminergic therapy for at least 1 month prior to the experiment
You likely can't join if
- Any contraindication for taVNS (e.g., ear lesions, pacemakers, defibrillators, or other electronic devices)
- Previous vagotomy or previous application of electrical stimulation to the ear or brain, or treatment with high-intensity focused ultrasound (HIFU)
- Voice or speech disorders caused by other medical conditions
- MoCA score below 21
- Psychotic symptoms or hallucinations; a diagnosis of psychiatric illness
- Systolic blood pressure above 160 mm Hg, and diastolic blood pressure above 100 mm Hg
See the full eligibility criteria
- Being a member of the Association or be interested in joining;
- Idiopathic PD diagnosis, stages 2-3 according to the Hoehn \& Yahr scale; confirmed by neurologist
- Ability to walk independently for at least 1 minute ant turn 180° without assistance;
- Exhibiting symptoms of hypokinetic dysarthria;
- On stable dopaminergic therapy for at least 1 month prior to the experiment
- Any contraindication for taVNS (e.g., ear lesions, pacemakers, defibrillators, or other electronic devices)
- Previous vagotomy or previous application of electrical stimulation to the ear or brain, or treatment with high-intensity focused ultrasound (HIFU)
- Voice or speech disorders caused by other medical conditions
- MoCA score below 21
- Psychotic symptoms or hallucinations; a diagnosis of psychiatric illness
- Systolic blood pressure above 160 mm Hg, and diastolic blood pressure above 100 mm Hg
- Inability to attend sessions;
- Concomitant neurological, orthopaedic, cardiac, respiratory or active medical/oncological condition that would affect participation
The study team makes the final eligibility decision.
Where it's taking place
- A Coruña, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include A Coruña, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.