NCT04707378

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 13, 2021

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

January 11, 2021

Last Update Submit

January 11, 2021

Conditions

Parkinson DiseaseDepressionCognitive Impairment

Keywords

Parkinson's DiseaserTMSDepressionCognitive ImpairmentNavigationDorsal Prefrontal Cortex

Outcome Measures

Primary Outcomes (2)

  • Hamilton Depression Scale（HAMD）

    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.

    1 months

  • Beck Depression Inventory（BDI）

    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.

    1 months

Secondary Outcomes (19)

  • Hamilton Anxiety Scale（HAMA）

    1 months

  • Beck Anxiety Inventory（BAI）

    1 months

  • Mini-mental State Examination（MMSE）

    1 months

  • Montreal Cognitive Assessment Scale（MoCA）

    1 months

  • Named test of the Aphasia Battery of Chinese

    1 months

  • +14 more secondary outcomes

Study Arms (2)

active left DLPFC navigated-rTMS

ACTIVE COMPARATOR

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.

Device: repetitive transcranial magnetic stimulation(rTMS)

sham left DLPFC navigated-rTMS

SHAM COMPARATOR

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.

Device: repetitive transcranial magnetic stimulation(rTMS)

Interventions

repetitive transcranial magnetic stimulation(rTMS)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.

active left DLPFC navigated-rTMSsham left DLPFC navigated-rTMS

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. Secondary Parkinson's syndrome caused by vascular factors, toxins, drugs, etc., or Parkinson's superimposed syndrome.
  • \. 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseDepressionCognitive Dysfunction

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavioral SymptomsBehaviorCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Lijuan Wang, Ph.D

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lijuan Wang, Ph.D

CONTACT

+86 020 83827812-10402wljgd68@163.com

Shuolin Jiang, BS

CONTACT

+86 020 83827812-50653jiangshuolin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 13, 2021

Study Start

December 30, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 13, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

CN(1)