Navigated Repetitive Transcranial Magnetic Stimulation for Parkinson's Disease With Depression or Cognitive Impairment

Last updated: January 11, 2021
Sponsor: Guangdong Provincial People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Learning Disorders

Mild Cognitive Impairment

Depression

Treatment

N/A

Clinical Study ID

NCT04707378
GDREC2020181H(R1)
  • Ages 18-85
  • All Genders

Study 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

Inclusion Criteria:

    1. Patients between 18 and 85 years of age with idiopathic PD (diagnosed as "confirmedPD" or "likely PD" according to the 2015 MDS Parkinson's diagnostic criteria),regardless of gender.
  1. Meet the DSM-IV diagnostic criteria for depressive episodes. 3. If there is acombination of anti-Parkinsonian medications, the anti-Parkinsonian medication regimenand dose must remain stable for ≥ 28 days and be maintained at that dose for theduration of treatment.
  2. Not taking any antidepressant medication for the last 2 months. 5. thesubject/their legal representative is able to comply with the study protocol and visitschedule.
  3. The patient or his/her legal guardian agrees to participate in this trial and signsan informed consent form.

Exclusion

Exclusion Criteria:

    1. Secondary Parkinson's syndrome caused by vascular factors, toxins, drugs, etc., orParkinson's superimposed syndrome.
  1. PD patients with persistent head tremor. 3. Dementia. 4. Patients with suicidaltendencies and psychotic symptoms. 5. Patients with consciousness disorders, historyof stroke, severe neurological/psychiatric disorders such as transient ischemic attackand other severe organic diseases within 1 year prior to screening (Visit 1) 6. Havecontraindications to rTMS(e.g., implantation of cochlear implants, deep brainstimulation, pacemakers, medical pumps, and other metal-containing devices nearstimulation coils; history of epilepsy; history of traumatic brain injury, braintumor, encephalitis, cerebrovascular disease, cerebral metabolic disease; sleepdeprivation, unrecovered jet lag, intoxication, overexertion; pregnancy; severe orrecent heart disease, etc.) 7. Have contraindications to MRI scanning (including metalimplants, retractors, braces, or claustrophobia).

Study Design

Total Participants: 42
Study Start date:
December 30, 2020
Estimated Completion Date:
December 31, 2021

Connect with a study center

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

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