Trial Outcomes & Findings for Evaluation of Long-term Effect of Resonator Therapy on Parkinson's Disease (PD) (NCT NCT00862537)

NCT ID: NCT00862537

Last Updated: 2011-07-08

Results Overview

The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item quality of life questionnaire for patients with Parkinson's Disease (PD) that evaluates the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. The PDQ-39 Single Index (SI) score is the weighted addition of scores on all 8 dimension and ranges from 0 (no disease impact) to 100 (severe disease impact).

• Recruitment status: COMPLETED
• Target enrollment: 18 participants
• Primary outcome timeframe: baseline and 11 months
• Results posted on: 2011-07-08

Participant Flow

Participant milestones

Measure	Active Resontaor Device Therapy active pico-tesla magnetic fields Resonator device therapy
Overall Study STARTED	18
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Long-term Effect of Resonator Therapy on Parkinson's Disease (PD)

Baseline characteristics by cohort

Measure	Active Resontaor Device Therapy n=18 Participants active pico-tesla magnetic fields Resonator device therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 11 months

The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item quality of life questionnaire for patients with Parkinson's Disease (PD) that evaluates the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. The PDQ-39 Single Index (SI) score is the weighted addition of scores on all 8 dimension and ranges from 0 (no disease impact) to 100 (severe disease impact).

Outcome measures

Measure	Active Resontaor Device Therapy n=18 Participants active pico-tesla magnetic fields Resonator device therapy
Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months	4.96 scores on a scale Standard Deviation 1.1

Adverse Events

Active Resontaor Device Therapy

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

Allen S. Braswell CEO

Pico-Tesla Magnetic Therapies, LLC

Phone: 303 795-3222

Email: abraswell@pico-tesla.com

Results disclosure agreements

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