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IRCT20260511069343N1 IRCT 2026-06-06 Esfahan University of Medical Sciences Investigating the effectiveness of a vibrating glove in improving symptoms and quality of life in Parkinson's patients Clinical Evaluation of Vibrotactile Coordinated Reset Stimulation in Motor and Non-motor Symptoms of Parkinson’s Disease: A Double-Blind, Placebo-Controlled Trial 2026-06-22 anticipated 58 Pending https://irct.ir/trial/90001 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is the first clinical trial of vibrotactile coordinated reset stimulation (vCRS) in Iran, utilizing an innovative stimulation protocol. A unique feature of this design is the inclusion of the thumb in the stimulation process to enhance the engagement of sensorimotor pathways. Furthermore, unlike many similar studies, this project employs advanced neurophysiological assessments, namely electroencephalography (EEG), in addition to clinical indices, to investigate changes in beta-band power and phase-amplitude coupling, thereby objectively monitoring the neural desynchronization process. Additionally, the twelve-week follow-up period after intervention cessation allows for the evaluation of the induced neuroplasticity capacity, Randomization description: 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, Blinding description: 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. 3 Idiopathic Parkinson's Disease. Intervention 1: Intervention group: Intervention group: Application of Vibrotactile Coordinated Reset Stimulation (Model: Neuroset PD-Basic V3). The device delivers 250 Hz vibratory pulses in a quasi-random 3:2 (on: off) burst pattern to the fingertips. Stimulation intensity is calibrated to each patient's sensory threshold. The intervention lasts for 12 weeks, 5 days per week, consisting of two 2-hour sessions per day with a 1-hour rest interval, conducted in a. Intervention 2: Control group: Application of a sham device (placebo) with identical appearance, weight, and user interface. Instead of organized stimulation, the device delivers non-therapeutic random vibrations lacking the coordinated reset pattern. The temporal protocol is identical to the intervention group (12 weeks, 5 days per week, two 2-hour sessions per day with a 1-hour rest interval) to maintain study blinding. Yes - There is a plan to make this available What will be shared: 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. When: 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. To whom: 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: 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. Where to obtain: 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 How to obtain: 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. Comments:
public Mohammad Saadatnia
Al-Zahra University Hospital, Soffeh Blvd, Isfahan, Iran
isfahan Iran (Islamic Republic of) 8174675731 +98 31 3822 0000 mosaadatnia@yahoo.com Esfahan University of Medical Sciences scientific Mohammad Saadatnia
Al-Zahra University Hospital, Soffeh Blvd, Isfahan, Iran
isfahan Iran (Islamic Republic of) 8174675731 +98 31 3822 0000 mosaadatnia@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Participants aged between 45 and 80 years Clinical diagnosis of idiopathic Parkinson's disease based on international criteria. Being in stages II to IV of the Hoehn and Yahr scale. Presence of moderate to severe tremor, rigidity, or bradykinesia. Minimum score of 20 in the Movement Disorder Society - Unified Parkinson’s Disease Rating Scale part III (MDS-UPDRS III). At least 30% motor improvement in response to dopaminergic medication Maintenance of a stable dopaminergic medication regimen for at least three months prior to enrollment 45 years 80 years Both A Mini-Mental State Examination (MMSE) score < 24 or a diagnosis of dementia Significant psychiatric or neurological disorders, history of traumatic brain injury, seizures, or past brain surgery Presence of severe comorbidities or systemic diseases. Abnormalities in vibration sensation or skin disorders at the fingertips. Recent Deep Brain Stimulation (DBS) or other neurosurgical interventions within the past three months. Pregnancy, breastfeeding, or planning to become pregnant Participation in any other clinical trial within the past 30 days. G20 Parkinson's disease Treatment - Devices Treatment - Devices Intervention group: Intervention group: Application of Vibrotactile Coordinated Reset Stimulation (Model: Neuroset PD-Basic V3). The device delivers 250 Hz vibratory pulses in a quasi-random 3:2 (on: off) burst pattern to the fingertips. Stimulation intensity is calibrated to each patient's sensory threshold. The intervention lasts for 12 weeks, 5 days per week, consisting of two 2-hour sessions per day with a 1-hour rest interval, conducted in a Control group: Application of a sham device (placebo) with identical appearance, weight, and user interface. Instead of organized stimulation, the device delivers non-therapeutic random vibrations lacking the coordinated reset pattern. The temporal protocol is identical to the intervention group (12 weeks, 5 days per week, two 2-hour sessions per day with a 1-hour rest interval) to maintain study blinding. Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) score to assess motor function. Timepoint: Measurements at baseline (before intervention), weeks 3, 6, 9, and 12 after the start of the intervention, and a final follow-up at week 24 (12 weeks post-intervention). Method of measurement: Completion of the standardized assessment form by a neurologist based on Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale. Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part IV (MDS-UPDRS IV) score to assess motor complications of therapy. Timepoint: Measurements at baseline (before intervention); weeks 3, 6, 9, and 12 after the start of the intervention; and a final follow-up at week 24 (12 weeks post-intervention). Method of measurement: Movement Disorder Society-Unified Parkinson's Disease Rating Scale, Part IV: Motor Complications. Changes in beta-band oscillatory power and phase-amplitude coupling in brain electrical signals. Timepoint: Baseline (before intervention) and week 12 (end of intervention). Method of measurement: Recording brain signals using Electroencephalography. Total score of health-related quality of life in patients with Parkinson's disease. Timepoint: Baseline, week 6, week 12, and week 24 (follow-up). Method of measurement: Using the Parkinson's Disease Questionnaire-39. Incidence of potential adverse events and device tolerability index by participants. Timepoint: Continuously during the 12-week intervention and final assessment at week 24. Method of measurement: Patient self-report checklist and clinical examination by a neurologist. Non-motor experiences of daily living score in patients with Parkinson's disease. Timepoint: Baseline, week 12, and week 24 (follow-up). Method of measurement: Part One of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale. Esfahan University of Medical Sciences Esfahan University of Medical Sciences Private Benefactor Approved 2026-04-29 Research Ethics Committees of Research Ethics Committee of the "Alzahra Research Centers" Vice-Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)