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

NCT ID: NCT04707378

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-30
• Study Completion Date: 2021-12-31

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.

Conditions

Parkinson Disease; Depression; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

active left DLPFC navigated-rTMS

Each patient will be given 10 treatment sessions per week for 2 weeks (a total of 10 sessions). In each rTMS session, 1200 pulses of stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left DLPFC. Each session is 20 minutes long and will be consisted of 10Hz stimulation trains (active) over the left DLPFC.

Group Type: ACTIVE_COMPARATOR

repetitive transcranial magnetic stimulation(rTMS)

Intervention Type: DEVICE

Each patient will be given 10 treatment sessions per week for 2 weeks (a total of 10 sessions). In each rTMS session, 1200 pulses of stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left DLPFC. Each session is 20 minutes long and will be consisted of 10Hz stimulation trains (active) over the left DLPFC. For sham control rTMS blocks, the coil will be oriented 90◦ away from the scalp so that no pulses perturbed underlying neural tissue.

sham left DLPFC navigated-rTMS

Each patient will be given 10 treatment sessions per week for 2 weeks (a total of 10 sessions). In each rTMS session, 1200 pulses of sham stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left DLPFC. Each session is 20 minutes long and will be consisted of 10Hz stimulation trains (sham) over the left DLPFC.

Group Type: SHAM_COMPARATOR

repetitive transcranial magnetic stimulation(rTMS)

Intervention Type: DEVICE

Each patient will be given 10 treatment sessions per week for 2 weeks (a total of 10 sessions). In each rTMS session, 1200 pulses of stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left DLPFC. Each session is 20 minutes long and will be consisted of 10Hz stimulation trains (active) over the left DLPFC. For sham control rTMS blocks, the coil will be oriented 90◦ away from the scalp so that no pulses perturbed underlying neural tissue.

Interventions

repetitive transcranial magnetic stimulation(rTMS)

Each patient will be given 10 treatment sessions per week for 2 weeks (a total of 10 sessions). In each rTMS session, 1200 pulses of stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left DLPFC. Each session is 20 minutes long and will be consisted of 10Hz stimulation trains (active) over the left DLPFC. For sham control rTMS blocks, the coil will be oriented 90◦ away from the scalp so that no pulses perturbed underlying neural tissue.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lijuan Wang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lijuan Wang, Ph.D

Role: CONTACT

wljgd68@163.com

+86 020 83827812-10402

Shuolin Jiang, BS

Role: CONTACT

jiangshuolin@gmail.com

+86 020 83827812-50653

Facility Contacts

Lijuan Wang, Ph.D, MD

Role: primary

wljgd68@163.com

+86 020 83827812-10402

Shuolin Jiang, BS

Role: backup

jiangshuolin@gmail.com

+86 020 83827812-50653

Other Identifiers

GDREC2020181H(R1)

Identifier Type: -

Identifier Source: org_study_id