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

NCT00862537 | Completed Results DMC

• 1 other identifier: PD Ext
• Study Type: observational
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

An extension study for subjects with prior participation in previous resonator studies using low level magnetic fields to treat some of the symptoms of idiopathic Parkinson's Disease.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 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).

  baseline and 11 months

Study Arms (1)

Active Resonator magnetic field therapy

Administration of active magnetic fields with the Resonator Device

Device: Resonator Device

Interventions

Resonator Device DEVICE

active pico-tesla magnetic fields treatment for Parkinson's disease individuals

Active Resonator magnetic field therapy

Eligibility Criteria

• Age: 30 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Previous participants enrolled in one of two prior pico-tesla Magnetic Therapies Resonator device studies using magnetic fields for treating Parkinson's Disease (PD) symptoms.

You may qualify if:

• Prior participation in pico-tesla pilot studies: NCT00779155 \& NCT00863226
• Willing and able to abstain from partaking in non-essential new treatments for Parkinson's disease symptoms during the course of participation of the study.
• Will and able to abstain from all non-essential new medications that could affect PD and/or any of its associated symptoms for the duration of the study.
• Willing to notify the investigator right away of any changes in medication use or therapies that is prescribed and deemed necessary by the subjects physicians.
• Adequate contraceptive measures for female subjects
• Capable of giving full written informed consent

You may not qualify if:

• Not a participant in IRC#'s 07102 or 07021
• No active brain tumors, strokes, hydrocephalus
• Chronic pain not associated with PD
• Any other condition which might prevent subject from comfortably sitting for 1.5 hours
• Consumption of medications that can produce Parkinsonism type symptoms
• Major psychiatric disturbance
• Epilepsy
• HIv and other autoimmune disorders
• Cancer within last 2 years
• History of ECt
• Diabetic neuropathy
• Uncontrolled HTN
• Advanced Pulmonary disease
• Known heart conditions such as repetitive history of cardiac arrythmias
• Previous surgeries for PD

Sponsors & Collaborators

• pico-tesla Magnetic Therapies, LLC: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Allen S. Braswell CEO
• Organization: Pico-Tesla Magnetic Therapies, LLC

abraswell@pico-tesla.com

303 795-3222

Study Officials

• Jerry I Jacobson, PhD., DMD.

  pico-tesla Magnetic Therapies, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: March 17, 2009
• Study Start: April 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 8, 2011
• Results First Posted: July 8, 2011

Record last verified: 2011-06