Effects of STN DBS on Cognition and Brain Networks in PD Patients Analyzed Based on EEG and fNIRS
NCT06175897, Not applicable, Unknown, Zhiqi Mao
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of STN DBS on Cognition and Brain Networks in PD Patients Analyzed Based on EEG and fNIRS | ClinicalTrials.gov |
| NCT number | NCT06175897 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Zhiqi Mao | ClinicalTrials.gov |
| Conditions | Parkinson's Disease, Executive Function, Electroencephalogram, Functional Near - Infrared Spectroscopy | ClinicalTrials.gov |
| Interventions | Deep Brain Stimulation, non-Deep Brain Stimulation | ClinicalTrials.gov |
| First posted | 2023-12-19 | ClinicalTrials.gov |
| Last updated | 2023-12-19 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in EEG-fNIRS performance | up to 1 month (DBS-on) ,6 months，12 months | To explore the differences in cognitive brain network changes in PD patients by using EEG-fNIRS photofusion technology. The EEG-fNIRS bimodal brain network of PD patients were constructed, and the network characteristic indexes, such as node degree, characteristic path length, and clustering coefficient, were counted. The cognitive differences of PD patients were interpreted by the actual physiological state represented by the brain network feature indicators, for example, a high node entry degree means high information inflow in the brain area where the node is located, short feature path length means high efficiency of whole-brain information transfer in the patient, and large clustering coefficient means high degree of modularity in the brain area of the PD patient. These characteristic indexes can better reflect PD patients' cognitive state and change differences. | ClinicalTrials.gov |
| Secondary | Change in Stroop scores | up to 1 month (DBS-on), 6 months, 12 months | Stroop A, B, and C elapsed time per card, number of correct (timing accurate to 0.01 s). The metrics reflecting the amount of interference (Stroop interference effect, SIE) include: SIE elapsed time = card C elapsed time - card B elapsed time; SIE correct number = card B correct number - card C correct number. The larger the SIE is, the lower the interference suppression effect is, and the more serious the impairment of executive function is. The indexes observed in this study include the number of correct and elapsed times of cards A, B, and C, the number of elapsed time and correct number of SIE, the elapsed time of cards (C-A-B), the rate of increase of elapsed time (C-B)/A, the rate of decrease of correct number (B-C)/A, and the elapsed time/correct number of each card. | ClinicalTrials.gov |
| Secondary | Change in Trail Making Test A and B scores | up to 1 month (DBS-on), 6 months, 12 months | TMT-A, and TMT-B recording indicators include: TMT-A elapsed time number (timing accurate to 0.01s); TMT-B elapsed time number (timing accurate to 0.01s); Number of TMT-A and TMT-B error connection reminders, number of pen lifts; Interference Error Coefficient (IE): (TMT-A - TMT-B) / TMT-A | ClinicalTrials.gov |
| Secondary | Change in Mini-mental State Examination scores | up to 1 month (DBS-on), 6 months, 12 months | Mini-mental State Examination (MMSE) will be used to evaluate the general cognitive function. MMSE ranges from 0 to 30, and a higher value represents a better outcome. | ClinicalTrials.gov |
| Secondary | Change in Neuropsychiatric Inventory (NPI) scores | up to 1 month (DBS-on), 6 months, 12 months | The Neuropsychiatric Inventory will be used to measure neuropsychiatric symptoms. It ranges from 0 to 144, and higher value represents a worse outcome. | ClinicalTrials.gov |
| Secondary | Change in Activities of Daily Living scores | up to 1 month (DBS-on), 6 months, 12 months | Activities of Daily Living (ADL) scale will be used to assess the change of life quality. It ranges from 20 to 80. The "20" represents normal life ability and the higher score presents the worse life ability. | ClinicalTrials.gov |
| Secondary | Change in Montreal Cognitive Assessment scores | up to 1 month (DBS-on), 6 months, 12 months | Montreal Cognitive Assessment (MoCA) will be used to evaluate the general cognitive function. MoCA ranges from 0 to 30, and higher value represents a better outcome. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)