Trial Outcomes & Findings for Evaluation of a Millimeter Wave Emission Bracelet for Improving Parkinson's Disease Symptoms (NCT NCT04648150)

NCT ID: NCT04648150

Last Updated: 2024-12-13

Results Overview

Decrease of 3.25 points or more in the Movement Disorder Society Unified Parkinson Disease Rating Scale III from inclusion. The Movement Disorder Society Unified Parkinson Disease Rating Scale III (MDS-UPDRS III score evaluation) will be performed under ON Dopa conditions and blinded from the randomization arm. The MDS-UPDRS III varies from 0 to199, a higher score meaning a worse outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: two months after inclusion
• Results posted on: 2024-12-13

Participant Flow

Participant milestones

Measure	VERUM An active wave emission bracelet for a period of 2 months. Then delivery of a second active medical device for a period of 4 months Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms: Evaluation of a millimeter wave emission bracelet -type medical device for improving Parkinson's disease symptoms: multicenter, double-blind randomized controlled trial	SHAM An inactive wave emission bracelet for a period of 2 months of use then delivery of an active medical device from M2 to M6 after inclusion. Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms: Evaluation of a millimeter wave emission bracelet -type medical device for improving Parkinson's disease symptoms: multicenter, double-blind randomized controlled trial
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	VERUM n=30 Participants An active wave emission bracelet for a period of 2 months. Then delivery of a second active medical device for a period of 4 months Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms: Evaluation of a millimeter wave emission bracelet -type medical device for improving Parkinson's disease symptoms: multicenter, double-blind randomized controlled trial	SHAM n=30 Participants An inactive wave emission bracelet for a period of 2 months of use then delivery of an active medical device from M2 to M6 after inclusion. Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms: Evaluation of a millimeter wave emission bracelet -type medical device for improving Parkinson's disease symptoms: multicenter, double-blind randomized controlled trial	Total n=60 Participants Total of all reporting groups
Age, Continuous	69.5 years n=30 Participants	66.5 years n=30 Participants	68.0 years n=60 Participants
Sex: Female, Male Female	16 Participants n=30 Participants	16 Participants n=30 Participants	32 Participants n=60 Participants
Sex: Female, Male Male	14 Participants n=30 Participants	14 Participants n=30 Participants	28 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	30 participants n=30 Participants	30 participants n=30 Participants	60 participants n=60 Participants

PRIMARY outcome

Timeframe: two months after inclusion

Decrease of 3.25 points or more in the Movement Disorder Society Unified Parkinson Disease Rating Scale III from inclusion.

The Movement Disorder Society Unified Parkinson Disease Rating Scale III (MDS-UPDRS III score evaluation) will be performed under ON Dopa conditions and blinded from the randomization arm.

The MDS-UPDRS III varies from 0 to199, a higher score meaning a worse outcome.

Outcome measures

Measure	VERUM n=30 Participants An active wave emission bracelet for a period of 2 months. Then delivery of a second active medical device for a period of 4 months Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms: Evaluation of a millimeter wave emission bracelet -type medical device for improving Parkinson's disease symptoms: multicenter, double-blind randomized controlled trial	SHAM n=30 Participants An inactive wave emission bracelet for a period of 2 months of use then delivery of an active medical device from M2 to M6 after inclusion. Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms: Evaluation of a millimeter wave emission bracelet -type medical device for improving Parkinson's disease symptoms: multicenter, double-blind randomized controlled trial
Assessment of the Effectiveness of Two Months of Use of the Remedee Endorphin Band Medical Device in Improving Motor Disorders in Patients With Parkinson's Disease	6 Participants	13 Participants

Adverse Events

VERUM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SHAM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Amélie YAVCHITZ

Hopital fondation Rothschild

Phone: +33148036454

Email: ayavchitz@for.paris

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place