Effect and Mechanism of Brain Stimulation for Parkinson's Disease With Cognitive Impairment

NCT06090682 | Recruiting

• 1 other identifier: TianjinHH-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to apply structural and functional brain network neuroimaging techniques combined with image post-processing methods to explore the differences in brain network changes in PD patients with cognitive impairment after DBS or TMS.

Conditions

Parkinson Disease; Cognitive Impairment

Keywords

Parkinson Disease; Cognitive Impairment; Deep brain stimulation; Transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• Montreal Cognitive Rating Scale(MoCA)

  The Montreal Cognitive Rating Scale was used to assess the overall cognitive status of patients before and after treatment

  December 2023 to December 2026

• verbal fluency test (VF)

  VF test was used to assess frontal executive function and related language function

  December 2023 to December 2026

Secondary Outcomes (1)

• the third part of the Unified Parkinson's Disease Rating Scale (UPDRS III)

  December 2023 to December 2026

Study Arms (1)

Cognitive Impairment (CI) group and No Cognitive Impairment (NCI) group

We intend to recruit 200 patients with primary PD to undergo DBS surgery or only TMS treatment according to whether the surgical indication is available. We will observe the changes in cognitive function of patients before and after different brain stimulation treatments. Parkinson's disease patients with cognitive impairment after brain stimulation were divided into cognitive impairment group, and those without cognitive impairment after treatment were divided into no cognitive impairment group

Device: Deep Brain Stimulation(DBS) and Transcranial Magnetic Stimulation(TMS)

Interventions

Deep Brain Stimulation(DBS) and Transcranial Magnetic Stimulation(TMS) DEVICE

We observed the changes in cognitive function of patients before and after different brain stimulation treatments, and further compared the effects of different brain stimulation treatments on cognitive function of PD patients and the related mechanisms according to whether DBS surgery was performed or TMS therapy was given only according to the surgical indications.

Cognitive Impairment (CI) group and No Cognitive Impairment (NCI) group

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Recruiting 200 patients with primary Parkinson's disease, aged less than 75 years old, regardless of gender, without prior brain injury, and with a history of brain surgery

You may qualify if:

• \. The clinical diagnosis of PD is consistent with the United Kingdom Parkinson's Disease Society Brain Bank criteria, with disease duration over 5 years, acute levodopa motor response ≥30%, and indication for STN-DBS.

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300070, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Zhao Guangrui, doctor

CONTACT

+86 18956405513; Guangrui-Zhao@hotmail.com

Feng Keke, doctor

CONTACT

+86 18920195507; fengke1976@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 14, 2023
• First Posted: October 19, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)