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Trial Outcomes & Findings for Study of Magnetic Fields for Treatment of Parkinson's Disease (NCT NCT00779155)

NCT ID: NCT00779155

Last Updated: 2011-07-12

Results Overview

The UPDRS is used to measure different aspects of Parkinson's Disease (PD). The UPDRS subscale II assesses how PD affects a person's daily life, with scores ranging from 0-52, with 52 representing greatest severity. The UPDRS subscale III assesses how PD affects how a person moves about, with scores ranging from 0-108, with 108 representing greatest severity. The combination of these 2 scores is used in clinical trials and in clinical practice to get a good overall idea of how PD affects a person's life. Combined score ranges from 0-160, with 160 being greatest severity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Baseline and 8 weeks

Results posted on

2011-07-12

Participant Flow

Participant milestones

Participant milestones
Measure
Inactive Resonator Device
inactive magnetic fields with placebo fields
Active Resonator Device
Active pico-tesla magnetic fields
Overall Study
STARTED
6
6
Overall Study
COMPLETED
6
6
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Magnetic Fields for Treatment of Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Inactive Resonator Device
n=6 Participants
inactive magnetic fields with placebo fields
Active Resonator Device
n=6 Participants
Active pico-tesla magnetic fields
Total
n=12 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Age, Categorical
>=65 years
6 Participants
n=5 Participants
5 Participants
n=7 Participants
11 Participants
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: Analysis was by intention to treat and all enrolled subjects completed the entire protocol.

The UPDRS is used to measure different aspects of Parkinson's Disease (PD). The UPDRS subscale II assesses how PD affects a person's daily life, with scores ranging from 0-52, with 52 representing greatest severity. The UPDRS subscale III assesses how PD affects how a person moves about, with scores ranging from 0-108, with 108 representing greatest severity. The combination of these 2 scores is used in clinical trials and in clinical practice to get a good overall idea of how PD affects a person's life. Combined score ranges from 0-160, with 160 being greatest severity.

Outcome measures

Outcome measures
Measure
Inactive Resonator Device
n=6 Participants
inactive magnetic fields with placebo fields
Active Resonator Device
n=6 Participants
Active pico-tesla magnetic fields
Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects "on" State.
-1 scores on a scale
Standard Deviation .5
-5 scores on a scale
Standard Deviation 1.2

Adverse Events

Inactive Resonator Device

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Active Resonator Device

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

Results disclosure agreements

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