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NCT Number: NCT06912191

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

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.

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Key information

Conditions

Post-stroke Depression

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Left cerebellar TMS stimulation combined with the RECT task

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

Other names: RECT task, TMS

Right cerebellar TMS stimulation combined with the RECT task

Other

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

Other names: RECT task, TMS

Midline cerebellar TMS stimulation combined with the RECT task

Other

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

Other names: RECT task, TMS

Sham cerebellar TMS stimulation combined with the RECT task

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.

Other names: RECT task

The best stimulation protocol combined with left dorsolateral prefrontal cortex iTBS

Other

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

Other names: left dorsolateral prefrontal cortex iTBS, RECT task, TMS

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

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.

Other names: left dorsolateral prefrontal cortex iTBS

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

Other

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

Primary outcomes

  1. Montgomery-Asberg Depression Rating Scale，MADRS

    Time frame: Day1

    This scale will be the primary outcome measure for Experiment 2. Montgomery-Asberg Depression Rating Scale，MADRS: Extreme depression: MADRS >35; Major depression: MADRS >30; Moderate depression: MADRS >22; Mild depression: MADRS >12; Remission stage: MADRS <12.

  2. Electroencephalogram

    Time frame: Day 1

    EEG will be the main outcome measures for Experiment 1 and Experiment 2. EEG power in the delta, theta, alpha, beta band: the power spectral density (PSD) in unit^2/Hz Functional connectivity---Phase locking value (PLV): The value of PLV ranges from 0 to 1 Event related potentials in amplitude/μV

Secondary outcomes

  1. Mini-mental state examination,MMSE

    Time frame: Day 1

    Mini-mental state examination,MMSE: A score of 27-30: normal; Score < 27: cognitive impairment.

  2. Montreal Cognitive Assessment, MoCA

    Time frame: Day 1

    Montreal Cognitive Assessment, MoCA: The total score of the scale is 30 points, and the test result shows that the normal value is ≥26 points.

  3. Hamilton Depression Scale，HAMD

    Time frame: Day 1

    Hamilton Depression Scale，HAMD: A total score of more than 35 May indicate severe depression.

  4. Hamilton Anxiety Scale，HAMA

    Time frame: Day 1

    Hamilton Anxiety Scale，HAMA: The total score ≥29, may be severe anxiety; ≥21 points, there must be obvious anxiety; ≥14 points, definitely have anxiety; More than 7 points, may have anxiety; If the score is less than 7, there is no anxiety symptom

  5. Quick Inventory of Depressive Symptomatology Self-Report, QIDS-SR16

    Time frame: Day 1

    Quick Inventory of Depressive Symptomatology Self-Report, QIDS-SR16: The total score is calculated on a scale of 0 to 27, with higher scores being associated with higher levels of depression.

  6. Response time

    Time frame: Day 1

    Recording their response times in seconds: The average reaction time of subjects in the facial expression recognition task to judge each facial expression picture.

  7. Accuracy rates

    Time frame: Day 1

    Recording their accuracy rates in % during the task: The average correct rate at which subjects judged each expression picture in the facial expression recognition task.

Study contacts

Contact information is provided by the study sponsor or research team.

Zihan Chen

CONTACT

[email protected]

+8618208812691

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Kunming Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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