Navigated Repetitive Transcranial Magnetic Stimulation for Parkinson's Disease With Depression or Cognitive Impairment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Guangdong Provincial People's Hospital
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Hamilton Depression Scale（HAMD）
- Last Updated
- 5 years ago
Overview
Brief Summary
Depressive symptoms are common non-motor symptoms in patients with Parkinson's disease and seriously affect the quality of life and prognosis of patients. Currently, treatment measures for patients with Parkinson's disease with depression are mainly limited to pharmacotherapy, but the side effects of antidepressants and their interaction with anti-Parkinsonian drugs limit the use of pharmacotherapy. Repetitive transcranial magnetic stimulation (rTMS) is a new painless and non-invasive neuromodulation technique that is commonly used in the treatment of depression. As the number of people with Parkinson's disease increases in China, the number of patients with Parkinson's disease and depression requiring rTMS treatment will also increase. The size and shape of individual brains, the distance between the stimulation coil and the responding neuronal tissue, and the location and orientation of anatomical structures are all different, and the use of common localization methods is usually limited by these individual anatomical differences. The traditional method relies on manual positioning of the coil, which is time-consuming and inefficient, and it is difficult to meet the requirements of position, angle, and coil orientation simultaneously. Studies have shown that the benefits of using navigation for rTMS treatment are up to twice as high as those of non-navigation methods. Therefore precise localization is a must for the future standardized application of rTMS in the development of patients with Parkinson's disease with depression. In this study, we applied repetitive transcranial magnetic stimulation with neuronavigation to treat patients with Parkinson's disease and depression, and reconstructed cephalometric models with individual cranial imaging data to individualize and precisely target stimulation sites, making rTMS more precise and effective in treating patients with Parkinson's disease and depression, and providing new avenues for further clinical and scientific research.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients between 18 and 85 years of age with idiopathic PD (diagnosed as "confirmed PD" or "likely PD" according to the 2015 MDS Parkinson's diagnostic criteria), regardless of gender.
- •Meet the DSM-IV diagnostic criteria for depressive episodes.
- •If there is a combination of anti-Parkinsonian medications, the anti-Parkinsonian medication regimen and dose must remain stable for ≥ 28 days and be maintained at that dose for the duration of treatment.
- •Not taking any antidepressant medication for the last 2 months.
- •the subject/their legal representative is able to comply with the study protocol and visit schedule.
- •The patient or his/her legal guardian agrees to participate in this trial and signs an informed consent form.
Exclusion Criteria
- •Secondary Parkinson's syndrome caused by vascular factors, toxins, drugs, etc., or Parkinson's superimposed syndrome.
- •PD patients with persistent head tremor.
- •Patients with suicidal tendencies and psychotic symptoms.
- •Patients with consciousness disorders, history of stroke, severe neurological/psychiatric disorders such as transient ischemic attack and other severe organic diseases within 1 year prior to screening (Visit 1)
- •Have contraindications to rTMS(e.g., implantation of cochlear implants, deep brain stimulation, pacemakers, medical pumps, and other metal-containing devices near stimulation coils; history of epilepsy; history of traumatic brain injury, brain tumor, encephalitis, cerebrovascular disease, cerebral metabolic disease; sleep deprivation, unrecovered jet lag, intoxication, overexertion; pregnancy; severe or recent heart disease, etc.)
- •Have contraindications to MRI scanning (including metal implants, retractors, braces, or claustrophobia).
Outcomes
Primary Outcomes
Hamilton Depression Scale（HAMD）
Time Frame: 1 months
The Hamilton Depression Rating Scale (HAMD) is a 24-item interviewer administered structure questionaire designed to assess symptoms of depression. Items are scored with a range of 0-4, though 11 of the items are scored between 0 and 2. A total score is then calculated of all items which can range from 0 to 74. A higher score is indicative of more depressive symptoms, and a lower score post-tx is indicative of better outcome.
Beck Depression Inventory（BDI）
Time Frame: 1 months
The Beck Depression Inventory (BDI) is a 21-item self-report questionaire that measures depressive symptoms. Each item is scored on a scale of 0-3, and items are summated to yield a total score. A higher score is indicative of greater symptoms of depression. Total scores may range between 0 and 63. A score greater than or equal of 14 is suggestive of clinically significant symptoms.
Secondary Outcomes
- Verbal fluency test（VFT）(1 months)
- Logical memory test（LMT）(1 months)
- Similarity test(1 months)
- Symbol Digit modalities test（SDMT）(1 months)
- Pittsburgh Sleep Quality Index (PSQI)(1 months)
- Beck Anxiety Inventory（BAI）(1 months)
- Mini-mental State Examination（MMSE）(1 months)
- Ten point clock test(1 months)
- Montreal Cognitive Assessment Scale（MoCA）(1 months)
- Delayed memory test（DMT）(1 months)
- Activity of Daily Living Scale（ADL）(1 months)
- Hamilton Anxiety Scale（HAMA）(1 months)
- Named test of the Aphasia Battery of Chinese(1 months)
- Digit span test（DST）(1 months)
- Parkinson's Disease Sleep Scale (PDSS-2)(1 months)
- Uniform Parkinson's Disease Rating Scale Ⅲ（UPDRSⅢ）(1 months)
- Modified Hoehn & Yahr scale（H-Y）(1 months)
- Parkinson's Disease Questionnaire（PDQ-39）(1 months)
- Epworth Sleepiness Scale (ESS)(1 months)