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

Overview

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.

Interventions

• Other 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. Duri
• Other Right cerebellar TMS stimulation combined with the RECT task
  Right cerebellar single-pulse TMS stimulation combined with the RECT task
• Other Midline cerebellar TMS stimulation combined with the RECT task
  Midline cerebellar single-pulse TMS stimulation combined with the RECT task
• 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.
• 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.
• 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.
• 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.

Primary outcome measures

• Montgomery-Asberg Depression Rating Scale，MADRS [Time frame: Day1]
• Electroencephalogram [Time frame: Day 1]

Secondary outcome measures (7)

• Mini-mental state examination,MMSE [Time frame: Day 1]
• Montreal Cognitive Assessment, MoCA [Time frame: Day 1]
• Hamilton Depression Scale，HAMD [Time frame: Day 1]
• Hamilton Anxiety Scale，HAMA [Time frame: Day 1]
• Quick Inventory of Depressive Symptomatology Self-Report, QIDS-SR16 [Time frame: Day 1]
• Response time [Time frame: Day 1]
• Accuracy rates [Time frame: Day 1]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06912191 · Shen-PJ-Ke-2024-138

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗