NCT06912191

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

Not yet recruiting NA Last updated 4 April 2025

What this trial tests

NA trial testing Left cerebellar TMS stimulation combined with the RECT task in Post-stroke Depression in 100 participants. Not yet recruiting.

Timeline

30 March 2025

Primary endpoint
28 February 2027

30 May 2027

Quick facts

Lead sponsor	The Second Affiliated Hospital of Kunming Medical University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	30 March 2025
Primary completion	28 February 2027
Estimated completion	30 May 2027

Drugs / interventions tested

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

Conditions studied

• Post-stroke Depression — all drugs for Post-stroke Depression →

Sponsor

The Second Affiliated Hospital of Kunming Medical University

Who can join

Adults 18 to 85, any sex, with Post-stroke Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.