Ignite Creation Date:
2024-05-05 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00753519
Status:
COMPLETED
Last Update Posted:
2012-11-15
First Post:
2008-09-13
Brief Title:
Transcranial Magnetic Stimulation to Treat Parkinsons Disease
Sponsor:
Mark Hallett
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Intermittent Theta-Burst Transcranial Magnetic Stimulation TBS for the Treatment of Parkinson Disease
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will look at the effects of transcranial magnetic stimulation TMS on symptoms of Parkinsons disease TMS is a method of brain stimulation that may be able to change the activity of the nerve cells of the brain This study will examine the effects of a specific pattern of stimulation called intermittent theta-burst TMS iTBS which uses repeated magnetic pulses delivered in short bursts
People with mild to moderately severe Parkinsons disease who are between 40 and 80 years of age and whose main problems are slow movement and stiffness may be eligible for this study
Participants undergo the following tests and procedures
Random assignment to real or placebo sham iTBS treatment
iTBS sessions real or sham 4 times a week for 2 consecutive weeks For this test the subject sits in a comfortable chair A wire coil is held on the subjects scalp and a brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain The subject hears a click and may feel a pulling sensation on the skin under the coil There may be a twitch in the muscles of the face arm or leg
Test of gait walk hand and arm movements before and after each session The gait test requires walking 10 meters about 30 yards in the same corridor with the same shoes
Extended testing The first and last gait tests done before starting iTBS and after the eighth session require coming off any Parkinsons medication for at least 12 hours before the test On these test days subjects also undergo a clinical examination short neuropsychological test battery a computer-based reaction time test and depression and quality-of-life rating scales These procedures are repeated in a follow-up visit 1 month after the last session
People with mild to moderately severe Parkinsons disease who are between 40 and 80 years of age and whose main problems are slow movement and stiffness may be eligible for this study
Participants undergo the following tests and procedures
Random assignment to real or placebo sham iTBS treatment
iTBS sessions real or sham 4 times a week for 2 consecutive weeks For this test the subject sits in a comfortable chair A wire coil is held on the subjects scalp and a brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain The subject hears a click and may feel a pulling sensation on the skin under the coil There may be a twitch in the muscles of the face arm or leg
Test of gait walk hand and arm movements before and after each session The gait test requires walking 10 meters about 30 yards in the same corridor with the same shoes
Extended testing The first and last gait tests done before starting iTBS and after the eighth session require coming off any Parkinsons medication for at least 12 hours before the test On these test days subjects also undergo a clinical examination short neuropsychological test battery a computer-based reaction time test and depression and quality-of-life rating scales These procedures are repeated in a follow-up visit 1 month after the last session
Detailed Description:
Objective
To demonstrate cumulative and long-lasting improvement of parkinsonian symptoms by iTBS and its safety in PD patients
Study population
Patients 40-80 years of age with PD Hoehn and Yahr disease stage of 2 to 4 while off being on a regimen including levodopa with a total dose of medication equal to more than 300 mg of levodopa including their dopamine agonist agents and having problems with walking and needing 6 seconds or more to walk a 10-meter distance
Design
Randomized double-blind placebo sham-controlled study Enrollment of 30 patients with PD in 2 groups real versus sham stimulation Performance 8 interventions of iTBS with large circular coil over motor and prefrontal cortex on both sides Assessment with standard tests of motor function over a one-month period
Outcome measure
The primary endpoint is change in gait speed as assessed by the time it takes to walk 10 m
Secondary endpoints include changes in bradykinesia as assessed by measuring the time it takes to do ten combined hand and arm movements and in total and motor UPDRS score
To demonstrate cumulative and long-lasting improvement of parkinsonian symptoms by iTBS and its safety in PD patients
Study population
Patients 40-80 years of age with PD Hoehn and Yahr disease stage of 2 to 4 while off being on a regimen including levodopa with a total dose of medication equal to more than 300 mg of levodopa including their dopamine agonist agents and having problems with walking and needing 6 seconds or more to walk a 10-meter distance
Design
Randomized double-blind placebo sham-controlled study Enrollment of 30 patients with PD in 2 groups real versus sham stimulation Performance 8 interventions of iTBS with large circular coil over motor and prefrontal cortex on both sides Assessment with standard tests of motor function over a one-month period
Outcome measure
The primary endpoint is change in gait speed as assessed by the time it takes to walk 10 m
Secondary endpoints include changes in bradykinesia as assessed by measuring the time it takes to do ten combined hand and arm movements and in total and motor UPDRS score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 08-N-0212 | None | None | None |