Clinical trial NCT06737549: Effect of Specific Mode Electroacupuncture Stimulation Combined with NGF on Dysphagia After Ischaemic Stroke: a Pilot Randomized Controlled Trial
Official title: Effect of Specific Mode Electroacupuncture Stimulation Combined with NGF on Dysphagia After Ischaemic Stroke: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ischemic Stroke
Dysphagia
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ischemic stroke is a common clinical disease, often accompanied by dysphagia. At present, clinical treatment for patients with dysphagia after ischemic stroke is limited. The emergence of NGF has surprised the field of neurorehabilitation, but the clinical effect is not satisfactory. The main problem is that NGF is a macromolecular material with a molecular weight of 13.4 KD, which is difficult to penetrate the blood brain barrier. A large number of previous studies in our team have found that electroacupuncture with specific stimulation mode can open the blood brain barrier and induce NGF into the brain. Therefore, the purpose of this study is to investigate the effect of specific mode electroacupuncture stimulation combined with NGF treatment on patients with dysphagia after ischemic stroke and to explore the mechanism of this combination therapy to improve brain function, which creates a new method and theoretical basis for nerve rehabilitation of integrated traditional Chinese and Western medicine.


Eligibility criteria: Inclusion Criteria:

1. Patients with first-ever ischemic stroke confirmed by Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI);
2. Onset time ranged from 15 days to 180 days;
3. Aged 18 to 80 years old, male or female;
4. Dysphagia confirmed by a videofluoroscopic swallowing study (VFSS);
5. Patients who are able to accept and comply with acupuncture, electroacupuncture treatment, gluteal intramuscular injection, and have good compliance;
6. Have provided signed consent and exhibit willingness to participate in the trial.
7. Women who are lactating, pregnant or intending to get pregnant;

Exclusion Criteria:

1. Patients with dysphagia before ischemic stroke onset or dysphagia not caused by ischemic stroke;
2. Patients with severe cognitive impairment;
3. Patients with severe cardiac, hepatic, and renal dysfunction, as well as severe coagulation abnormalities;
4. Patients with other abnormal test results who are deemed unsuitable to participate in this study by the investigator.
5. Multiple occurrences of stroke, or a history of craniocerebral surgery, or cerebral infarction caused by trauma or brain tumors.
6. Patients with severe neurological deficits prior to ischemic stroke, such as visual and auditory impairments, aphasia, agnosia, severe hemiplegia, and other conditions.
7. Women who are lactating, pregnant or intending to get pregnant;
8. Patients with a history of needle fainting or with skin infections at the acupuncture site.
9. Cardiac pacemaker carrier;
10. Patients allergic to NGF;
11. The inability to undergo VFSS;
12. Patients with a medication history that may alter cortical excitability within the past 2 months.
13. Patients who are currently participating in other clinical trials or have participated in clinical trials that ended within the last 3 months.

Primary outcomes:
measure: Functional Oral Intake Scale (FOIS)
timeFrame: week 0, week 2, week 4, week 6, week 12
Secondary outcomes:
measure: Dysphagia Outcome and Severity Scale (DOSS)
timeFrame: week 0, week 6
measure: Penetration Aspiration Scale (PAS)
timeFrame: week 0, week 6
measure: modified Rankin Scale (mRS)
timeFrame: week 0, week 2, week 4, week 6
measure: Modified Barthel Index (MBI)
timeFrame: week 0, week 2, week 4, week 6
measure: Oxygenated hemoglobin and deoxygenated hemoglobin in cerebral cortex
timeFrame: week 0, week 6
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
References:
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