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

Kunming Medical University

Status: Not yet enrolling

Conditions: Post-stroke Depression

Treatments: Other: Midline cerebellar TMS stimulation combined with the RECT task; Other: The best stimulation protocol combined with left dorsolateral prefrontal cortex iTBS; Other: Right cerebellar TMS stimulation combined with the RECT task; Other: Left cerebellar TMS stimulation combined with the RECT task; Other: Sham left dorsolateral prefrontal cortex iTBS stimulation, sham cerebellar TMS stimulation, and sham RECT task.; Other: Left dorsolateral prefrontal cortex iTBS stimulation, as well as sham TMS stimulation and sham RECT task.; Other: Sham cerebellar TMS stimulation combined with the RECT task

Study type: Interventional

Funder types: Other

Identifiers

NCT06912191

Shen-PJ-Ke-2024-138

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 7 patient groups

LC TMS combined with the RECT task (Experiment1)

Experimental group

Description:

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

Treatment:

Other: Left cerebellar TMS stimulation combined with the RECT task

RC TMS combined with the RECT task (Experiment1)

Experimental group

Description:

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

Treatment:

Other: Right cerebellar TMS stimulation combined with the RECT task

MC TMS combined with the RECT task (Experiment1)

Experimental group

Description:

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

Treatment:

Other: Midline cerebellar TMS stimulation combined with the RECT task

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

Sham Comparator group

Description:

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.

Treatment:

Other: Sham cerebellar TMS stimulation combined with the RECT task

Combined Stimulus Intervention group （Experiment 2）

Experimental group

Description:

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

Treatment:

Other: The best stimulation protocol combined with left dorsolateral prefrontal cortex iTBS

iTBS treatment group（Experiment 2）

Experimental group

Description:

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

Treatment:

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

Traditional treatment group（Experiment 2）

Sham Comparator group

Description:

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

Treatment:

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