Clinical trial NCT05187975: Integrated Rehabilitation in Treating Post-stroke Depression
Official title: Integrated Rehabilitation in Treating Post-stroke Depression: Study Protocol for a Multicentre, Prospective, Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-stroke Depression
Keywords: post-stroke depression
integrated rehabilitation
acupuncture
traditional Chinese medicine
repetitive transcranial magnetic stimulation
randomized controlled trial
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Zhejiang General Hospital of Armed Police
name: Hangzhou Hospital of Traditional Chinese Medicine
name: Jinhua Second Hospital
First posted: 2022-01-12
Enrollment: 202
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in hamilton depression (HAMD) scale
timeFrame: Baseline, at 4-week during treatment, at 8-week follow-up
measure: Change in self-rating depression scale (SDS)
timeFrame: Baseline, at 4-week during treatment, at 8-week follow-up
measure: Change in activity of daily living (ADL) scale
timeFrame: Baseline, at 4-week during treatment, at 8-week follow-up
Secondary outcomes:
measure: Change in montreal cognitive assessment (MoCA) scale
timeFrame: Baseline, at 4-week during treatment, at 8-week follow-up
measure: Change in the simple fugl-meyer assessment of motor function (FMA) scale
timeFrame: Baseline, at 4-week during treatment, at 8-week follow-up
measure: Change in pittsburgh sleep quality index (PSQI)
timeFrame: Baseline, at 4-week during treatment, at 8-week follow-up
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: Third Affiliated Hospital of Zhejiang Chinese Medical University
name: Hong Gao
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen J, Shen K, Fan L, Hu H, Li T, Zhang Y, Gao H. Integrative medicine in treating post-stroke depression: Study protocol for a multicenter, prospective, randomized, controlled trial. Front Psychol. 2022 Aug 29;13:923506. doi: 10.3389/fpsyg.2022.923506. eCollection 2022.