50 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Parkinson's Disease
|ClinicalTrials.gov Identifier: NCT00977184|
Recruitment Status : Completed
First Posted : September 15, 2009
Results First Posted : December 27, 2012
Last Update Posted : December 27, 2012
- In transcranial magnetic stimulation (TMS), a device creates a short-lasting magnetic field which induces an electric current in the brain leading to a change in the activity of brain cells. There are different effects on the brain with different rates of stimulation. In a previous study in people with Parkinson's disease, repetitive TMS (rTMS) given at a particular rate temporarily improved their ability to walk. A faster rate of rTMS may be more effective in treating symptoms than the rate originally used.
- This study will compare active rTMS to inactive (sham or Placebo) rTMS. Half of the people in this study will have active rTMS; the other half will have no brain stimulation with rTMS.
- To see if a faster rate of transcranial magnetic stimulation is a more effective treatment for the symptoms of Parkinson's disease than the slower rates that have been studied.
- Individuals between 40 and 80 years of age who have been diagnosed with mild or moderate Parkinson's disease.
- Participants must currently be taking Sinemet or dopamine agonists drugs (e.g., bromocriptine, cabergoline, pergolide, pramipexole, ropinirole, apomorophine, and rotigotine), and are willing to continue their same treatments for the duration of the study.
- This study requires 11 outpatient visits to the NIH Clinical Center over 6 weeks. Participants can also be admitted and stay as an inpatient in the NIH Clinical Center for the entire study period (for the 10 visits during the first weeks and the follow-up visit a month later).
- Initial visit will consist of a physical examination; a test of participants' time to walk 10 meters; and questions about memory, mood, and quality of life. Participants should not take Parkinson's disease medications for 12 hours before this visit; once the examinations and tests are complete, participants will be able to take the medications. Researchers will repeat the tests 1 hour after participants take the medication.
- TMS sessions: 8 TMS sessions (4 sessions per week) over 2 weeks. Each stimulation session will last half an hour. Half of the participants will receive active TMS; the other half will receive sham TMS.
- The first 10 participants will have additional tests to study the safety of rapid TMS in patients with Parkinson's disease.
- A day after completing the last TMS session, participants will repeat the same tests as the first visit before and after taking their medication as in the first assessment and respond to questions about mood, memory, and quality of life.
- One month after completing the last TMS session, participants will repeat the same tests as the first visit before and after taking their medication.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Procedure: 50 HZ Repetitive TMS Procedure: Sham rTMS||Phase 1 Phase 2|
To demonstrate cumulative and long-lasting improvement of parkinsonian symptoms by 50 Hz rTMS (repetitive transcranial magnetic stimulation) and its safety in Parkinson's Disease (PD) patients.
Up to 30 PD patients in Hoehn and Yahr disease stage 2-4 while off medication will be enrolled. Patients must be receiving more than 300 mg of levodopa (including dopamine agonists) and have gait problems.
This is a randomized, double-blind, placebo (sham)-controlled study of 26 patients with PD in 2 groups (real versus sham stimulation). The study involves performance (8 interventions) of 50 Hz rTMS with large circular coil over the motor cortex on both sides of the brain. Assessment of PD symptoms with standard tests of motor function will be performed over a one-month period.
The primary endpoint include the changes in gait speed as assessed by the time it takes to walk 10 meters and the changes in bradykinesia as assessed by measuring the time it takes to do 10 combined hand and arm movements.
Secondary endpoints include the changes in the total, motor and activities of daily living Unified Parkinson's Disease Rating Scale (UPDRS) score.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Controlled Study of 50 Hz Repetitive Transcranial Magnetic Stimulation for the Treatment of Parkinson's Disease|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
|Experimental: Real rTMS||
Procedure: 50 HZ Repetitive TMS
|Sham Comparator: Sham rTMS||
Procedure: Sham rTMS
- Gait Speed [ Time Frame: Baseline, 1 day post rTMS ]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 rTMS and sham rTMS. 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 and 1 day post intervention.
- Bradykinesia [ Time Frame: Baseline, 1 day post rTMS ]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 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 rTMS ]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 rTMS ]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). The Motor UPDRS was administered at baseline and at 1 day post rTMS or sham. Subjects were assessed on medication and off medication.
- Activities of Daily Living UPDRS [ Time Frame: Baseline, 1 day post rTMS ]The Activities of Daily Living Unified Parkinson's Disease Rating Scale (ADL UPDRS) is a self evaluation of the activities of daily living. The following variables are rated: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed, falling, freezing when walking, walking, tremor and sensory complaints. Each variable is rated on a scale of 0 (normal) to 4 (severe impairment). A total score for the ADL UPDRS ranges from 0 (no impairment) to 52 (severe impairment).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977184
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|