Clinical trial NCT04707378: Navigated Repetitive Transcranial Magnetic Stimulation for Parkinson's Disease With Depression or Cognitive Impairment
Official title: Navigated Repetitive Transcranial Magnetic Stimulation for Parkinson's Disease With Depression or Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Depression
Cognitive Impairment
Keywords: Parkinson's Disease
rTMS
Depression
Cognitive Impairment
Navigation
Dorsal Prefrontal Cortex
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 1. 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.

  2. Meet the DSM-IV diagnostic criteria for depressive episodes. 3. 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.

  4. Not taking any antidepressant medication for the last 2 months. 5. the subject/their legal representative is able to comply with the study protocol and visit schedule.

  6. The patient or his/her legal guardian agrees to participate in this trial and signs an informed consent form.

Exclusion Criteria:

* 1. Secondary Parkinson's syndrome caused by vascular factors, toxins, drugs, etc., or Parkinson's superimposed syndrome.

  2. PD patients with persistent head tremor. 3. Dementia. 4. Patients with suicidal tendencies and psychotic symptoms. 5. 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) 6. 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.) 7. Have contraindications to MRI scanning (including metal implants, retractors, braces, or claustrophobia).

Primary outcomes:
measure: Hamilton Depression Scale（HAMD）
timeFrame: 1 months
measure: Beck Depression Inventory（BDI）
timeFrame: 1 months
Secondary outcomes:
measure: Hamilton Anxiety Scale（HAMA）
timeFrame: 1 months
measure: Beck Anxiety Inventory（BAI）
timeFrame: 1 months
measure: Mini-mental State Examination（MMSE）
timeFrame: 1 months
measure: Montreal Cognitive Assessment Scale（MoCA）
timeFrame: 1 months
measure: Named test of the Aphasia Battery of Chinese
timeFrame: 1 months
measure: Similarity test
timeFrame: 1 months
measure: Symbol Digit modalities test（SDMT）
timeFrame: 1 months
measure: Verbal fluency test（VFT）
timeFrame: 1 months
measure: Logical memory test（LMT）
timeFrame: 1 months
measure: Delayed memory test（DMT）
timeFrame: 1 months
measure: Digit span test（DST）
timeFrame: 1 months
measure: Ten point clock test
timeFrame: 1 months
measure: Uniform Parkinson's Disease Rating Scale Ⅲ（UPDRSⅢ）
timeFrame: 1 months
measure: Modified Hoehn & Yahr scale（H-Y）
timeFrame: 1 months
measure: Activity of Daily Living Scale（ADL）
timeFrame: 1 months
measure: Parkinson's Disease Questionnaire（PDQ-39）
timeFrame: 1 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1 months
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 1 months
measure: Parkinson's Disease Sleep Scale (PDSS-2)
timeFrame: 1 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Lijuan Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: