Transcranial Magnetic Stimulation to Treat Parkinson's Disease
|ClinicalTrials.gov Identifier: NCT00753519|
Recruitment Status : Completed
First Posted : September 16, 2008
Results First Posted : November 15, 2012
Last Update Posted : November 15, 2012
This study will look at the effects of transcranial magnetic stimulation (TMS) on symptoms of Parkinson's 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 Parkinson's 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 subject's 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 Parkinson's 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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Real iTBS Device: Sham iTBS||Phase 1 Phase 2|
To demonstrate cumulative and long-lasting improvement of parkinsonian symptoms by iTBS and its safety in PD patients.
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Intermittent Theta-Burst Transcranial Magnetic Stimulation (TBS) for the Treatment of Parkinson Disease|
|Study Start Date :||September 2008|
|Primary Completion Date :||September 2009|
|Study Completion Date :||September 2009|
Experimental: Real iTBS
iTBS is a novel form of excitatory rTMS that may induce larger and longer lasting changes that standard rTMS. iTBS consists of bursts of 3 pulses at 50 Hz repeated at 200 msec intervals. The 2 sec trains were repeated 20 times every 10 sec. iTBS was applied to the primary motor and the dorsolateral prefrontal cortex bilaterally.
Device: Real iTBS
Real iTBS was performed in 8 sessions over 2 successive weeks, a session/day for 4 consecutive days/week.
Sham Comparator: Sham iTBS
The sham coil was placed in the same areas, and made a similar sound as the rTMS but was without a magnetic pulse.
Device: Sham iTBS
Sham iTBS was performed in 8 sessions over 2 successive weeks, a session/day for 4 consecutive days/week.
- Gait Speed [ Time Frame: baseline, 1 day post iTBS ]Gait speed was assessed by measuring the time it takes to walk 10 meters. Subject's gait speed was measured while on medication and off medication for each group, i.e., real iTBS and sham iTBS. Two trials were averaged for each condition. Patients were instructed to walk fast without taking the risk of falling, wearing the same shoes and consistently using assistive devices if needed. Gait speed was measured at baseline, 1 day post intervention, and 1 month post intervention.
- Bradykinesia [ Time Frame: baseline, 1 day post iTBS ]Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then were abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.
- Total UPDRS Score [ Time Frame: baseline, 1 day post iTBS ]The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall assessment scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score consists of mentation, behavior, mood, activities of daily living and motor components, and ranges from 0 (not affected) to 176 (most severely affected). The total UPDRS score is obtained from patient examination, interview and patient questionnaires.
- Motor UPDRS [ Time Frame: baseline, 1 day post iTBS ]The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753519
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|