N/A
N=24
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Apathy in Parkinson's Disease
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00955032 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Feb 2012
Primary outcome: Primary: Apathy Evaluation Scale (AES) — 19.6; 18.8; 17.9; 16.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High-Frequency Repetitive Transcranial Magnetic Stimulation (Device); Sham Repetitive Transcranial Magnetic Stimulation (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apathy Evaluation Scale (AES) |
19.6; 18.8; 17.9; 16.8 | — |
| SECONDARY Lille Apathy Rating Scale (LARS) |
-15.6; -18.9; -20.1; -22.1 | — |
| SECONDARY Beck Depression Inventory-Second Edition (BDI-II) |
17.1; 17.8; 11.8; 11.8 | — |
| SECONDARY Hamilton Depression Rating Scale (HAM-D) |
12.5; 11.9; 7.9; 8.5 | — |
Summary
The purpose of this research study is to attempt to treat apathy in Parkinson's disease (PD) using high-frequency repetitive transcranial magnetic stimulation (rTMS) of the brain and to investigate the patterns of brain activation that may be involved in apathy. It is hypothesized that high-frequency rTMS of the left mid-dorsolateral frontal cortex will improve apathy in PD.
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.
Data sourced from ClinicalTrials.gov (NCT00955032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.