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Electro-acupuncture for Long Covid Neuropsychiatric Symptoms

Sponsor
Hong Kong Baptist University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05890508
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
22
Anticipated Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, a 16-week randomized, sham-controlled, double-blinded clinical trial will be conducted to to investigate the efficacy and safety of electro-acupuncture compared to sham acupuncture for treatment of long covid neuropsychiatric symptoms.

Condition or Disease Intervention/Treatment Phase
  • Device: Acupuncture
  • Device: Sham-acupuncture
 N/A

Detailed Description

This is a prospective, randomized, sham-controlled, double-blinded and multiple center trial on electro-acupuncture for treating neuropsychiatric symptoms in long covid patients. A total of 150 participants will be randomly assigned to the electro-acupuncture and the sham-control group with 1:1 ratio. Both groups will receive 32 sessions of interventions during 16-week treatment duration (2 session per week), and will be followed up for 8 weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
All patients and the investigators including the research assessors, the statistician, and the researchers interacting with the patients except the one who conducts the acupuncture therapy will be blinded.
Primary Purpose:
Treatment
Official Title:
Electro-acupuncture for Long Covid Neuropsychiatric Symptoms: a Prospective, Randomized Sham-controlled, Double-blinded Clinical Trial
Anticipated Study Start Date :
Jun 30, 2023
Anticipated Primary Completion Date :
Jan 31, 2025
Anticipated Study Completion Date :
Apr 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Electro-acupuncture group

The electro-acupuncture intervention will be conducted for 2 session per week during 16-week treatment duration, and will be followed up for 8 weeks. In this study, 7 acupoints are chosen:GV20(Baihui), EX-HN1(Sishencong), EX-HN3(Yintang), SP6(Sanyinjiao), ST36(Zusanli), ST40(Fenglong), and LR3(Taichong). The puncture is made in accordance with the standards of traditional Chinese medicine, to a depth of 1 to 3 cm depending on the thickness of the local tissues. The acupoints are subjected to 2-5 Hz electroacupuncture from an electroacupuncture device at an intensity (5 to 10 mA) that can produce a muscle twitch acceptable to the participant.

Device: Acupuncture
Disposable acupuncture needles (0.20 mm in diameter) are are used in the study. The acupoints are GV20(Baihui), EX-HN1(Sishencong), EX-HN3(Yintang), SP6(Sanyinjiao), ST36(Zusanli), ST40(Fenglong), and LR3(Taichong). Electrical stimulation will be delivered with waves at 2-5 Hz from an electroacupuncture device. The needles will be retained in position for 30 minutes.
Sham Comparator: Sham-acupuncture group

For subjects assigned to the sham control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2/ 0.30 x 30mm) will be applied to serve as a sham control at the corresponding non-acupoints, leave 0.5 cun from the corresponding acupoints, with the same stimulation modality. Addtionally, the stimulation will be a "pseudo stimulation", which will be given by connecting the needle to the incorrect output socket of the electrical acupuncture stimulation instrument. The credibility and validity of this system have been well demonstrated. .

Device: Sham-acupuncture
Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2"/ 0.30 x 30mm) will be applied to serve as a sham control at the same acupoints with the same stimulation modality and then connecting the needle to the incorrect output socket of the electrical acupuncture stimulation instrument. The sham points are "pseudo stimulation".

Outcome Measures

Primary Outcome Measures

  1. Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale [At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).]

    The MMSE can evaluate of five different domains of cognitive functions: (1) Orientation, with a maximum of 10 points, (2) Memory, with a maximum of 6 points, (3) Attention and calculation, with a maximum of 5 points, (4) Language, with a maximum of 8 points, and (5) Design copying, with a maximum of 1 point. It has a maximum score of 30, with MMSE score denotes severity of cognitive impairment as follows; mild: MMSE 21 to 24, moderate: MMSE 10 to 20, severe: MMSE less than 10.

  2. Depression on the Chinese Beck Depression Inventory (CBDI) [At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).]

    The scale has a total of 21 questions, with an overall score of 63, 14-19 being mild depression, 20-28 being moderate depression, and above 29 being severe depression.

Secondary Outcome Measures

  1. Score of Insomnia Severity Index (ISI) [At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).]

    The Insomnia Severity Index in Chinese includes 5 questions to assess the severity and impact of insomnia, on an 0 to 4 scale, with the higher score reflecting worse insomnia symptoms.

  2. Score of Brief Fatigue Inventory-Taiwanese (BFI-T) Form [At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).]

    BFI-T form is to assess the severity of fatigue and the impact of fatigue on daily functioning. Scoring Respondents rate each item on a 0-10 numeric scale, with 0 meaning "no fatigue" and 10 meaning "fatigue as bad as you can imagine." Scores are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).

  3. Score of the Short Form 12 (SF12) [At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).]

    The SF-12V2 is a widely used generic HRQoL instrument, and its Chinese version has been validated and normed in the general Chinese population in Hong Kong. It consists of 12 questions measuring eight domains of health, including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The scores are generated using an algorithm to generate a combined physical and mental health score for comparison with normative data. In the normative data: 1) the mean score was set to 50; 2) a score > 50 indicated better physical or mental health than the mean; 3) a score < 50 indicated worse physical or mental health than the mean.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • adults over 18 years of age to 80;

  • history of SARS-CoV-2 PCR+ at least 4 weeks prior to study entry; SARS-CoV-2 negative (PCR) at study entry;

  • at least one persistent neurological symptom (impaired concentration, headache, sensory disturbances, or depression, or "brain fog") that began around the time of the acute COVID-19;

  • willing and able to consent, complete all assessment and study procedures.

Exclusion Criteria:

  • any chronic or remote neurological disorder (i.e. stroke, head trauma, epilepsy, tumor);

  • intellectual disability pre-existing to the Covid-19 episode;cardiovascular diseases such as arrhythmia, heart failure, myocardial infarction, and patients with cardiac pacemakers,

  • acute brain injury or acute encephalopathy from another aetiology than covid (e.g., sepsis, liver or renal failure, alcohol or drug withdrawal, drug toxicity);

  • documented pre-existing history of psychiatric illness, including substance abuse;

  • open-heart cardiac surgery or cardiac arrest during the last 6 months;

  • current hospitalization;

  • pregnant women.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhong Lidan Kowloon Tong Kowloon Hong Kong 637551

Sponsors and Collaborators

  • Hong Kong Baptist University

Investigators

  • Study Chair: Dong Jue Wei, MD, Hong Kong Baptist University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zhong Lidan, Assistant Professor, Hong Kong Baptist University
ClinicalTrials.gov Identifier:
NCT05890508
Other Study ID Numbers:
  • 2021HMRF
First Posted:
Jun 6, 2023
Last Update Posted:
Jun 6, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Post-Acute COVID-19 Syndrome

Study Results

No Results Posted as of Jun 6, 2023