Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Apathy in Parkinson's Disease (ReStore)
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Apathy, rTMS, Repetitive transcranial magnetic stimulation, Depression
Eligibility Criteria
Inclusion Criteria:
- diagnosis of "probable" PD, defined by the presence of at least 2 out of 3 cardinal motor features of PD (resting tremor, rigidity, and bradykinesia, plus a sustained and significant response to dopaminergic treatment);
- age 30 or over; and
- on stable medications for at least 30 days.
Exclusion Criteria:
- features suggestive of other causes of parkinsonism/ parkinson-plus syndromes;
- history of deep brain stimulation or ablation surgery, significant headaches, epilepsy or seizure disorder, mass brain lesions, or major head trauma leading to loss of consciousness of any length;
- family (1st degree relatives) history of epilepsy;
- evidence for dementia;
- presence of contraindications for functional magnetic resonance imaging (fMRI);
- history of schizophrenia, schizoaffective disorder, other psychosis, rapid-cycling bipolar illness, alcohol/drug abuse within the past year;
- need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;
- unstable medical condition such as diabetes, cardiac disease, hypertension;
- pregnancy; and
- colorblindness.
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
High-Frequency Repetitive Transcranial Magentic Stimulation
Sham Repetitive Transcranial Magentic Stimulation
High-Frequency repetitive transcranial magnetic stimulation patients randomized to this treatment will receive left prefrontal rTMS, each treatment will consist of 2000 stimuli (50 - 8-second trains of 40 stimuli at 5 Hz). We will administer rTMS trains every 30 seconds for 25 minutes. Stimulus intensity for the first and second trains will be 80 and 90% of Motor Evoked Potential (MEP) threshold, respectively.
Sham repetitive transcranial magnetic stimulation patients randomized to receive the sham rTMS will undergo the same procedure for identifying stimulus location used in patients receiving real rTMS. Simulated rTMS will be administered using Magstim Placebo 70 mm figure-of-8 shaped coils which produce discharge noise and vibration similar to a real 70 mm coil without stimulating the cerebral cortex. However, in addition to obvious coil discharge noise, rTMS also causes electrical stimulation of the scalp. We will simulate this experience by attaching surface electrodes underneath the sham coil and in contact with the scalp.