Investigating How the RECT Impacts Brain Functional States Through the ACC-cerebellar Loop

NCT ID: NCT06912191

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-30
• Study Completion Date: 2027-05-30

Brief Summary

Experiment1: Using a brain EEG-TMS combined system, researchers aim to investigate the impact of the rostral anterior cingulate cortexr (rACC)-engaging cognitive task (RECT) combined single-pulse TMS magnetic stimulation on theta neural oscillations in the medial frontal lobe. The study will be divided into 4 groups: the first group will receive left cerebellar single-pulse TMS stimulation combined with the RECT task, the second group will receive right cerebellar single-pulse TMS stimulation combined with the RECT task, the third group will receive midline cerebellar single-pulse TMS stimulation combined with the RECT task, and the fourth group will receive sham cerebellar single-pulse TMS stimulation combined with the RECT task. Divide the participants into groups of 15 people each, following a 1:1:1:1 ratio. Based on the above testing, the stimulus method that results in the most significant change in the midline of the frontal lobe will be identified.

Experiment 2: Based on the research from Experiment 1, the most significant approach affecting theta neural oscillations in the medial frontal gyrus will be identified. This stimulation protocol will be combined with left dorsolateral prefrontal cortex iTBS stimulation in Experiment 2. The research aim of Experiment 2 is to investigate the most effective stimulation method for enhancing midline theta neural oscillations in the frontal lobe, in combination with left dorsolateral prefrontal cortex iTBS, for the treatment of post-stroke depression patients. This study will include 40 post-stroke depressed patients, and each participant must meet the inclusion criteria. The first group of participants, consisting of 20 individuals, will receive the optimal combination intervention. The second group of participants will only receive iTBS stimulation, without any additional intervention strategies used in Experiment 1. Patients will undergo Hamilton Depression Scale assessment and resting state and task state EEG collection at baseline, one week after intervention, and two weeks after intervention.The primary outcome will be the Hamilton Depression Scale, with EEG-related data being analyzed as a secondary outcome. Task-oriented EEG detection will include both facial expression recognition paradigm and oddball experiment paradigm. Reaction time, accuracy, and completion status will be recorded simultaneously in the experiment. The experiment will record patients' tolerance and any adverse events that occur.

Conditions

Post-stroke Depression

Study Design

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

Study Groups

LC TMS combined with the RECT task (Experiment1)

Left cerebellar single-pulse TMS stimulation combined with the RECT task

Group Type: EXPERIMENTAL

Left cerebellar TMS stimulation combined with the RECT task

Intervention Type: OTHER

The first group will receive left cerebellar single-pulse TMS stimulation combined with the RECT task. RECT refers to rostral anterior cingulate cortexr (rACC)-engaging cognitive task. The theoretical basis of this task is that when subjects are in a state of focused attention, the power of theta neural oscillations in the midline of their frontal lobe will increase. By considering the features of post-stroke depression, this study combines the emotional recognition task with the RECT task. During each trial, individuals will view 4 faces consecutively, each displaying a different expression, and they will be required to memorize the sequence of expressions. Emoticons consist of joy, sorrow, and rage. After displaying four facial expressions, a brief text flowchart will appear. Participants need to check if the sequence reflected in the flowchart matches the order in which the four facial expressions appeared. If they match, click the left mouse button; if they do not match, click the

RC TMS combined with the RECT task (Experiment1)

Right cerebellar single-pulse TMS stimulation combined with the RECT task

Group Type: EXPERIMENTAL

Right cerebellar TMS stimulation combined with the RECT task

Intervention Type: OTHER

Right cerebellar single-pulse TMS stimulation combined with the RECT task

MC TMS combined with the RECT task (Experiment1)

Midline cerebellar single-pulse TMS stimulation combined with the RECT task

Group Type: EXPERIMENTAL

Midline cerebellar TMS stimulation combined with the RECT task

Intervention Type: OTHER

Midline cerebellar single-pulse TMS stimulation combined with the RECT task

Sham cerebellar single-pulse TMS stimulation combined with the RECT task (Experiment1)

Sham cerebellar single-pulse TMS stimulation combined with the RECT task, The TMS coil was placed at the cerebellar site but tilted 90° to prevent effective magnetic field penetration.

Group Type: SHAM_COMPARATOR

Sham cerebellar TMS stimulation combined with the RECT task

Intervention Type: OTHER

Sham cerebellar single-pulse TMS stimulation combined with the RECT task, The TMS coil was placed at the cerebellar site but tilted 90° to prevent effective magnetic field penetration.

Combined Stimulus Intervention group （Experiment 2）

Combined iTBS stimulation of the dorsolateral prefrontal cortex and TMS of the cerebellum with the RECT task intervention group

Group Type: EXPERIMENTAL

The best stimulation protocol combined with left dorsolateral prefrontal cortex iTBS

Intervention Type: OTHER

The optimal stimulation protocol determined in Experiment 1 combined with stimulation of the left dorsolateral prefrontal cortex.

iTBS treatment group（Experiment 2）

The group of participants will receive left dorsolateral prefrontal cortex iTBS stimulation, as well as sham cerebellar TMS stimulation and sham RECT task.

Group Type: EXPERIMENTAL

Left dorsolateral prefrontal cortex iTBS stimulation, as well as sham TMS stimulation and sham RECT task.

Intervention Type: OTHER

Subjects in the group underwent left dorsolateral prefrontal cortex iTBS stimulation, in addition to receiving sham TMS stimulation and participating in a sham RECT task. The sham RECT task involves having participants watch a continuous scroll of faces without needing to react.

Traditional treatment group（Experiment 2）

The group of participants will receive sham left dorsolateral prefrontal cortex iTBS stimulation, sham cerebellar TMS stimulation, and sham RECT task.

Group Type: SHAM_COMPARATOR

Sham left dorsolateral prefrontal cortex iTBS stimulation, sham cerebellar TMS stimulation, and sham RECT task.

Intervention Type: OTHER

The participants in this group received sham left dorsolateral prefrontal cortex iTBS stimulation, sham cerebellar TMS stimulation, and sham RECT task.

Interventions

Left cerebellar TMS stimulation combined with the RECT task

The first group will receive left cerebellar single-pulse TMS stimulation combined with the RECT task. RECT refers to rostral anterior cingulate cortexr (rACC)-engaging cognitive task. The theoretical basis of this task is that when subjects are in a state of focused attention, the power of theta neural oscillations in the midline of their frontal lobe will increase. By considering the features of post-stroke depression, this study combines the emotional recognition task with the RECT task. During each trial, individuals will view 4 faces consecutively, each displaying a different expression, and they will be required to memorize the sequence of expressions. Emoticons consist of joy, sorrow, and rage. After displaying four facial expressions, a brief text flowchart will appear. Participants need to check if the sequence reflected in the flowchart matches the order in which the four facial expressions appeared. If they match, click the left mouse button; if they do not match, click the

Intervention Type: OTHER

Right cerebellar TMS stimulation combined with the RECT task

Right cerebellar single-pulse TMS stimulation combined with the RECT task

Intervention Type: OTHER

Midline cerebellar TMS stimulation combined with the RECT task

Midline cerebellar single-pulse TMS stimulation combined with the RECT task

Intervention Type: OTHER

Sham cerebellar TMS stimulation combined with the RECT task

Sham cerebellar single-pulse TMS stimulation combined with the RECT task, The TMS coil was placed at the cerebellar site but tilted 90° to prevent effective magnetic field penetration.

Intervention Type: OTHER

The best stimulation protocol combined with left dorsolateral prefrontal cortex iTBS

The optimal stimulation protocol determined in Experiment 1 combined with stimulation of the left dorsolateral prefrontal cortex.

Intervention Type: OTHER

Left dorsolateral prefrontal cortex iTBS stimulation, as well as sham TMS stimulation and sham RECT task.

Subjects in the group underwent left dorsolateral prefrontal cortex iTBS stimulation, in addition to receiving sham TMS stimulation and participating in a sham RECT task. The sham RECT task involves having participants watch a continuous scroll of faces without needing to react.

Intervention Type: OTHER

Sham left dorsolateral prefrontal cortex iTBS stimulation, sham cerebellar TMS stimulation, and sham RECT task.

The participants in this group received sham left dorsolateral prefrontal cortex iTBS stimulation, sham cerebellar TMS stimulation, and sham RECT task.

Intervention Type: OTHER

Other Intervention Names

RECT task; TMS; RECT task; TMS; RECT task; TMS; RECT task; left dorsolateral prefrontal cortex iTBS; RECT task; TMS; left dorsolateral prefrontal cortex iTBS

Eligibility Criteria

Inclusion Criteria

• Onset of stroke <6 months ago, or >6 months since the last stroke event;
• Age >=18 years and <85 years (as the probability of Vascular Cognitive Impairment increases above 85);
• Patients with damage in the middle cerebral artery territory;
• NIHSS >4 and <26;
• mRS score >=2;
• Completion of CT or MRI;
• No neurological or psychiatric disorders; no impairment of consciousness; able to comply with relevant treatments; no severe cognitive dysfunction (MMSE >=15);
• All participants are right-handed; Sign the informed consent form.

Exclusion Criteria

• History of epilepsy or psychiatric disorders (including depression, anxiety, or schizophrenia);
• Severe comorbidities;
• History of medication use: benzodiazepines, baclofen, antidepressants;
• Non-compliance with the treatment plan;
• Acute-phase cerebral hemorrhage, acute infectious diseases;
• Severe suicidal tendencies in individuals with depression;
• Individuals suffering from severe headaches, high blood pressure, malignant tumors, open wounds, vascular embolism, leukopenia, etc.;
• Severe alcohol abuse;
• History of cranial surgery, individuals with metal implants in the brain;
• Individuals with an implanted cardiac pacemaker;
• NIHSS >26, MMSE <15;
• Any disease likely to prevent the patient from surviving more than one month;
• Pregnant individuals.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Second Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: lead

Responsible Party

Liqing Yao

Director, Department of Rehabilitation Medicine, the Second Affiliated Hospital of Kunming Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zihan Chen

Role: CONTACT

18208812691@163.com

+8618208812691

Other Identifiers

Shen-PJ-Ke-2024-138

Identifier Type: -

Identifier Source: org_study_id