Clinical Evaluation of Vibrotactile Coordinated Reset Stimulation in Motor and Non-motor Symptoms of Parkinson’s Disease: A Double-Blind, Placebo-Controlled Trial

To determine the efficacy, safety, and durability of vibrotactile coordinated reset stimulation (vCRS) on motor and non-motor symptoms of Parkinson's disease; to assess scores of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS); to investigate brain oscillations via electroencephalography (EEG), quality of life via the 39-item Parkinson's Disease Questionnaire (PDQ-39), and sleep via the Parkinson's Disease Sleep Scale-Revised (PDSS-2); and to analyze acoustic indices and medication dosage between the two intervention and placebo.

A randomized, controlled, parallel-group, double-blind, sham-controlled clinical trial of twenty-nine patients per group, with a twelve-week intervention period, and followed for twelve weeks

This double-blind study in a neurology clinic involves twelve weeks of intervention (two daily 2-hour vibratory stimulation sessions with a 1-hour rest interval). With patients and assessors blinded, evaluations include regular clinical scales and EEG.

inculsion: Age 45-80; Idiopathic PD (H&Y 2-4); MDS-UPDRS-III at least 20; stable medication. Exclusion: Dementia , history of brain surgery, seizures, or injury; finger sensory/skin disorders; pregnancy; concurrent clinical trial participation.

Active vCRS gloves , twice daily, 2 hours/session for 12 weeks, including thumb stimulation. Control: Identical sham gloves providing random vibration (placebo) following the same temporal protocol and clinical monitoring to ensure blinding.

Change in MDS-UPDRS Part III and Part IV scores from baseline to week 12; Changes in beta-band oscillations and phase-amplitude coupling in EEG data; Quality of life indices based on the PDQ-39 questionnaire; Occurrence of adverse events and device tolerability reported by patients.

Participants are assigned to the intervention and control groups using Stratified Randomization. Initially, patients are categorized into separate strata based on key variables, including disease severity (Hoehn & Yahr stage) and gender. Subsequently, within each stratum, group allocation is performed using random permuted blocks of variable sizes by an independent individual. This methodology ensures an appropriate balance between the groups and minimizes the potential for bias stemming from baseline confounding factors

This study is conducted in a double-blind manner. Participants are blinded using a placebo device that is physically identical to the active vCRS device but delivers no effective vibration. The Principal Investigator and Clinical Caregivers are blinded as an independent technician configures the device modes. Outcome Assessors performing clinical evaluations (e.g., MDS-UPDRS) are blinded to group assignments and have no access to the randomization list. Data Analysts will process the data using coded group labels (Group A/B) to remain blinded until the completion of the primary analysis.

In this study, individual participant data,including baseline demographic characteristics (excluding names, national ID numbers, or contact information), pre- and post-intervention scores on the MDS-UPDRS (both motor and non-motor sections), primary outcome measures, and secondary outcomes—will be fully available for potential sharing upon study completion and full de-identification of the individuals. This sharing will strictly encompass structured numerical and methodological data; identity-bearing documents or formal consent forms will not be disclosed to maintain patient confidentiality.

Starting date of availability: 6 months following the publication of the primary manuscript in a peer-reviewed journal. Duration of availability: The de-identified data will remain accessible for 3 years (36 months) from the starting date of availability.

Eligible Requesters: The de-identified individual participant data and study documents will be accessible exclusively to qualified researchers, academicians, and students affiliated with accredited academic institutions, universities, and formal research centers. Restrictions: Data access is strictly limited to non-commercial, scientific, and educational research purposes. Requesters from commercial industries, private pharmaceutical companies, or medical device corporations are not eligible to access the data independently, unless through an approved collaborative research agreement with the principal investigator and the sponsoring institution.

Conditions for Data Use & Allowed Analyses: 1. The shared de-identified data are strictly limited to secondary statistical analysis, clinical methodological evaluations, and purely educational purposes. 2. Any attempt to re-identify the study participants or link the data to other medical records is strictly prohibited. 3. Utilizing the study protocols, data dictionary, or analysis codes for commercial purposes, reverse engineering of the vibrotactile stimulation system, or copying the device technology is forbidden. 4. Any resulting publications or scientific presentations must properly cite the primary manuscript of this trial and acknowledge the Isfahan Neurosciences Research Center. Requirements and Mechanism for Access: Eligible requesters must submit the following documents to the Principal Investigator (Dr. Mohammad Saadatnia): 1. A formal, institutionally approved research proposal outlining the specific aims of the secondary analysis. 2. An official endorsement letter signed by the Vice-Chancellor for Research or the Dean of the applicant's affiliated university/institution. 3. A signed Data Sharing Agreement (DSA) executed by the primary requesting investigator, committing to all privacy and non-commercial terms.

Eligible requesters must submit their formal request along with the required documents (the approved research proposal and an institutional endorsement letter from the originating university) via email to the Principal Investigator: - Principal Investigator Email (Dr. Mohammad Saadatnia): mosaadatnia@yahoo.com - Co-Investigator Email (For faster follow-ups): amiratabakpr@gmail.com

Step 1 (Initial Screening & Document Verification - 2-3 weeks): Upon receiving the requester's email containing the research proposal and institutional letter, the co-investigator will verify the completeness of the documents and forward them to the Principal Investigator (Dr. Mohammad Saadatnia) for formal scientific review. Step 2 (Approval & DSA Execution - 2 weeks): If the scientific and methodological objectives are approved by the research team, the official Data Sharing Agreement (DSA) will be sent to the requester to be signed and stamped by their originating institution. Step 3 (Data Compilation & Delivery - 2 weeks): Following the receipt of the fully executed DSA, the de-identified clinical dataset and related methodological documents will be compiled and securely transferred to the requester via a secure link. Estimated Total Timeline: The entire process, from the initial submission to the final delivery of the data files, is estimated to take between 6 to 8 weeks (approximately 2 months). This timeline ensures meticulous compliance with participant privacy and data security protocols.