Integrated Rehabilitation in Treating Post-stroke Anxiety (IRTPA)

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status: Enrolling

Conditions: Post-stroke; Anxiety

Treatments: Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05147077

2021ZX010-A

Details and patient eligibility

About

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

Integrated rehabilitation has significant advantages in the treatment of PSA. 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 PSA. 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.

Full description

This randomized controlled trial will enroll 188 PSA 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 anxiety (HAMA) scale, self-rating anxiety scale (SAS), 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).

Enrollment: 188 estimated patients

Sex: All

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet the diagnostic criteria of cerebral infarction or cerebral hemorrhage with anxiety disorder, the type of depression and clinical syndrome of liver stagnation transforming into fire;
• 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;
• Anxiety level as mild or moderate (HAMA scores >= 7 and <= 21);
• Anxiety symptoms occur after the stroke in a clear temporal sequence;
• The course of the PSA 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 anxiety for nearly a month;
• People with unstable vital signs or patients with other mental disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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188 participants in 2 patient groups

Integrated rehabilitation group

Experimental group

Description:

This group will include 94 patients. On the basis of standard care, patients in this group will receive acupuncture, traditional Chinese medicine, repetitive transcranial magnetic stimulation.

Treatment:

Procedure: Acupuncture

Standard care group

Active Comparator group

Description:

The patients were recommended to take one oral tablet of escitalopram oxalate (10 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.

Treatment:

Procedure: Acupuncture