Integrated Rehabilitation in Treating Post-stroke Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-24

Study Completion Date

2024-12-31

Brief Summary

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Post-stroke depression (PSD) is a common complication of stroke that leads to dysfunction and reduces the quality of life. PSD exacerbates cognitive dysfunction, delays the recovery process, and increases the disability, mortality and recurrence rates of stroke. Therefore, early clinical treatments for PSD are important to improve the prognosis and restore the social functions of stroke patients.

Integrated rehabilitation has significant advantages in the treatment of PSD. First of all, there is a wide range of rehabilitation methods, such as acupuncture, traditional Chinese medicine, and repetitive transcranial magnetic stimulation, which have been proved to be effective for PSD. However, as the application of integrated rehabilitation becomes more and more widespread, its shortcomings are gradually emerging. For example, most of the treatment protocols used in clinical studies are based on personal experience of the investigators, a unified protocol has not yet been formed; treatment methods are still insufficient in standardization and reproducibility. More studies focus solely on the improvement of a certain symptom by a certain rehabilitation therapy, but ignore the important theoretical basis of the "holistic concept", thus showing the uneven clinical efficacy. For the above existing problems, it is necessary to conduct original and innovative research.

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Detailed Description

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This randomized controlled trial will enroll 202 PSD patients from the Third Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang General Hospital of Armed Police, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, and Jinhua Second Hospital. All patients will be randomly assigned to either the integrated rehabilitation group or the standard care group through a randomization system. The primary outcome will be assessed by hamilton depression (HAMD) scale, self-rating depression scale (SDS), and activity of daily living (ADL) scale. Secondary outcomes will include montreal cognitive assessment (MoCA) scale, the simple fugl-meyer assessment of motor function (FMA) scale and pittsburgh sleep quality index (PSQI).

Conditions

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Post-stroke Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Integrated rehabilitation group

This group will include 101 patients. On the basis of standard care, patients in this group will receive acupuncture, traditional Chinese medicine, repetitive transcranial magnetic stimulation .

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

Acupuncture:

Scalp acupuncture includes middle line of forehead (MS1), a front line by the forehead (MS2), and middle line of vertex (MS5), these acupoints are needled for 1 inch with the direction with scalp tilted 15-30 degrees.

Body acupuncture includes Yintang (DU29), Taichong (LR3), Shenmen (HT7), Neiguan (PC6), Danzhong (RN17), Qimen (LR14), Taixi (KI3).

Traditional Chinese medicine:

Chaihushugan Power: Chaihu 12g, Chenpi 12g, Chuanxiong 9g, vinegar Xiangfu 9g, Zhike 9g, Shaoyao 9g, roasted Gancao 3g.

Repetitive transcranial magnetic stimulation:

The CCY-I magnetic field stimulator from Wuhan Irid Medical Equipment New Technology Co is used, with a frequency of 10Hz.

Standard care:

The same as the standard care group.

Standard care group

The patients were recommended to take one oral tablet of paroxetine hydrochloride (20 mg) every morning after a meal for 4 weeks. Internal medicine includes lipid regulation, blood sugar control, anti-hypertension, anticoagulation, and other drugs. Moreover, general duty nursing and motor therapy are also needed.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

Acupuncture:

Scalp acupuncture includes middle line of forehead (MS1), a front line by the forehead (MS2), and middle line of vertex (MS5), these acupoints are needled for 1 inch with the direction with scalp tilted 15-30 degrees.

Body acupuncture includes Yintang (DU29), Taichong (LR3), Shenmen (HT7), Neiguan (PC6), Danzhong (RN17), Qimen (LR14), Taixi (KI3).

Traditional Chinese medicine:

Chaihushugan Power: Chaihu 12g, Chenpi 12g, Chuanxiong 9g, vinegar Xiangfu 9g, Zhike 9g, Shaoyao 9g, roasted Gancao 3g.

Repetitive transcranial magnetic stimulation:

The CCY-I magnetic field stimulator from Wuhan Irid Medical Equipment New Technology Co is used, with a frequency of 10Hz.

Standard care:

The same as the standard care group.

Interventions

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Acupuncture

Acupuncture:

Scalp acupuncture includes middle line of forehead (MS1), a front line by the forehead (MS2), and middle line of vertex (MS5), these acupoints are needled for 1 inch with the direction with scalp tilted 15-30 degrees.

Body acupuncture includes Yintang (DU29), Taichong (LR3), Shenmen (HT7), Neiguan (PC6), Danzhong (RN17), Qimen (LR14), Taixi (KI3).

Traditional Chinese medicine:

Chaihushugan Power: Chaihu 12g, Chenpi 12g, Chuanxiong 9g, vinegar Xiangfu 9g, Zhike 9g, Shaoyao 9g, roasted Gancao 3g.

Repetitive transcranial magnetic stimulation:

The CCY-I magnetic field stimulator from Wuhan Irid Medical Equipment New Technology Co is used, with a frequency of 10Hz.

Standard care:

The same as the standard care group.

Intervention Type PROCEDURE

Other Intervention Names

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Traditional Chinese medicine Repetitive transcranial magnetic stimulation Standard care

Eligibility Criteria

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Inclusion Criteria

* Meet the diagnostic criteria of cerebral infarction or cerebral hemorrhage with depression disorder, the type of depression and the clinical syndrome of liver qi stagnation;
* Patients with clear consciousness, stable vital signs, ability to understand and cooperate with instructions, barthel index (BI) \> 20, FMA (0-95), Mini-mental State Examination (MMSE) meet the following criteria: illiterate \> 17, primary school level \> 20, secondary school level (including technical secondary school) \> 22, and college level (including junior college) \> 23 points;
* 25 \<= age \<= 85 years, male or female;
* First episode of stroke, no personal or family history of mental disability before the stroke;
* Depression level as mild or moderate (HAMD scores \>= 7 and \<= 24);
* Depression symptoms occur after the stroke in a clear temporal sequence;
* The course of the PSD is limited to 2 weeks to 36 months after the stroke;
* Participants can understand the study protocol and written informed consent is signed.

Exclusion Criteria

* Patients with acute brain trauma, brain infection, effusion, or tumor occupation;
* There are intracranial metals and other foreign bodies (such as orthopedic materials, arterial clips, etc.), cardiac pacemakers, deep brain stimulators, and other electronic devices;
* Previous seizures, including primary and secondary seizures；
* Patients have severe complications in cardiovascular, liver, kidney or psychiatric history ;
* There is a significant cognitive impairment (MMSE: literacy \<= 17, primary school level \<= 20, secondary school level (including technical secondary school) \<= 22, and college level (including junior college) \<= 23 points) or hearing impairment, aphasia;
* Coma, dying or chronic illness;
* Patients have taken psychotropic drugs or been treated for depression for nearly a month;
* People with unstable vital signs or patients with other mental disorders.

Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No