The Effect of Acupuncture Treatment on Cognitive Functions and Brain Networks for Long COVID

NCT07355751 | Not Yet Recruiting

• 1 other identifier: 2025KL-086
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

Background of study: Long COVID(LC) is a prevalent sequalae of SARS-CoV-2 infection and can affect multiple organ systems. Cognitive dysfunction is one of the most common symptoms in LC with 22% prevalence. It can persist for years and significantly reduce patients' quality of life. Brain network is the neural basis underlying human cognitive processes. Diffusion tensor imaging (DTI) and functional magnetic resonance imaging(fMRI) research has revealed that alterations of network characteristics were associated with cognitive impairments across attention, memory, executive function and language in LC. Currently, there is no accepted therapy for cognitive impairment in LC. Acupuncture, as a Traditional Chinese Medicine therapy, has potential to improve cognitive deficits for LC. However, research focusing on the impact of acupuncture on cognitive functions in LC is rare. Additionally, no one has evaluated the mechanism of acupuncture improving cognitive functions in LC. Objective of the study: This study aims to assess the effect of acupuncture treatment on cognitive function and explore the central mechanism of acupuncture therapy in improving cognitive function for LC using cognitive assessments, DTI and resting-state fMRI. Study design: A prospective, three-armed, randomized controlled trial with DTI and rs-fMRI. Adults with LC will be randomly assigned to acupuncture, sham acupuncture, or waitlist control group in a 1:1:1 ratio, receiving 8-week intervention or waiting. Cognitive function and topological attributes of brain networks will be examined at baseline and 8th week. Study population: Patients fulfilling World Health Organization (WHO) criteria for LC will be included in this study.

Conditions

Long Covid

Keywords

Long COVID; cognitive function; acupuncture; neuropsychological test; brain network; magnetic resonance imaging; multimodal methods

Outcome Measures

Primary Outcomes (2)

• Change of Addenbrooke's Cognitive Examination-III total score from baseline to the end of 8 weeks

  Addenbrooke's Cognitive Examination-III is a cognitive screening tool, and the total score assess general cognitive function. The total score ranges from 0 to 100. Higher score indicates better general cognitive function

  Baseline and 8 weeks

• Change of Phonemic Fluency Test score from baseline to the end of 8 weeks

  Phonemic fluency test measures the number of correct words produced under restricted search conditions of phonemic(letter F) . Higher score indicates better language.

  Baseline and 8 weeks

Secondary Outcomes (27)

• Changes of Digit Span Test scores from baseline to the end of 8 weeks

  Baseline and 8 weeks

• Change of Symbol Digit Modality Test score from baseline to the end of 8 weeks

  Baseline and 8 weeks

• Changes of Trail Making Test scores from baseline to the end of 8 weeks

  Baseline and 8 weeks

• Changes of Rey Auditory Verbal Learning Test scores from baseline to the end of 8 weeks

  Baseline and 8 weeks

• Changes of Rey-Osterrieth Complex Figure Test scores from baseline to the end of 8 weeks

  Baseline and 8 weeks

Other Outcomes (1)

• The number of participants with treatment-related adverse events recorded in Case Report Form(CRF) at the end of treatment at 8 weeks

  8 weeks

Study Arms (3)

Verum Acupuncture group

EXPERIMENTAL

Acupoints with acupuncture treatment

Other: Acupuncture

Sham acupuncture group

SHAM COMPARATOR

Non-acupoints with sham acupuncture treatment

Other: Sham acupuncture

Waitlist control group

NO INTERVENTION

Acupoints with acupuncture treatment after 8-week waiting period

Interventions

Sham acupuncture OTHER

Nonpenetrating acupuncture on non-acupoints will be performed using Park sham acupuncture device (0.25 mm in diameter and 40 mm in length, Hwatuo, Suzhou, China) for participants. Two sets of non-acupoints will be alternatively acupunctured. The first set of sham acupoints includes bilateral non-acupoint 1, non-acupoint 2, non-acupoint 3, bilateral non-acupoint 4, bilateral non-acupoint 5. The second set consists of bilateral non-acupoint 6, bilateral non-acupoint 7, bilateral non-acupoint 8. The treatment consists of 24 sessions of 30 minutes, given within eight weeks (three sessions per week). A set of non-acupoints will be acupunctured each treatment session.

Sham acupuncture group

Acupuncture OTHER

Two sets of acupoints will be alternatively acupunctured. The first set of acupuncture points incudes Baihui (GV20), Shenting (GV24), bilateral Neiguan (PC6), Qihai (CV6), Guanyuan (CV4), bilateral Zusanli (ST36), bilateral Sanyinjiao (SP6). The second set of acupoints consist of Sishenchong (EX-HN1), bilateral Ganshu (BL18), bilateral Pishu (BL20), bilaetral Shenshu (BL23). The treatment consists of 24 sessions of 30 minutes, given within eight weeks (three sessions per week).A set of acupoints will be acupunctured each treatment session.

Verum Acupuncture group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years
• Fulfilling WHO criteria for long COVID
• History of confirmed COVID-19 through RT-PCR of nasopharyngeal swab or antigen test of nasal swab ;
• Having subjective cognitive problems
• Native Chinese speakers
• Right handedness
• Voluntary to participate in the study and signing the informed consent form.

You may not qualify if:

• Preexisting cognitive symptoms before COVID-19
• Previous or current diagnosis of chronic conditions that may affect cognitive performances (such as neurological, psychiatric disorders, organ failure, chronic infectious diseases)
• Prior loss of consciousness
• History of major surgery within a year
• Long-term use of drugs that may influence cognition(such as tranquilizer, antidepressant, immunosuppressor)
• Previous acupuncture treatment within 3 months
• Involvement of other clinical study within 4 weeks
• Obesity(BMI≥28)
• Sensory disorders(deafness, color blindness)
• Limb dysfunction
• Metal implantation
• Claustrophobia
• Pregnancy or lactation

Sponsors & Collaborators

• Tingting Luo: lead

Study Sites (2)

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 611130, China

Location

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 611130, China

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Tingting Luo

CONTACT

+86-18782007605; rose3719@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: data analysts
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 21, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)