Activation on LDPC Cortex With Different Acupoints: An fNIRS Study

NCT02711527 | Unknown

• 1 other identifier: UW16-008
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-labelled study to study the effect of the different acupoints combination under TCM treatment principles by fNIRS. The investigator aim to recruited 36 depression subjects and go through 6 acupuncture treatment sessions in 3 weeks. They will be divided into 2 groups by randomization. (Group A n=18, Group B n=18) The participants will receive 2 acupuncture session per week for 3 consecutively weeks. In each treatment session, all subjects in both groups will receive the same amount of needle insertion ( total 14 needles) , all needles will be retained for 30 minutes. The whole treatment will last for around 45 minutes. No sedation will be conducted. Subjects in Group A will receive 14 needles based on the TCM theory "Soothing liver-qi stagnation", all needles will be retained for 30 minutes. Acupoint combination: Taichong太衝 (LR 3), Ligou蠡沟 (LR 5), Zhongdu 中都(LR6), Xiguan膝關 (LR 7), Ququan曲泉 (LR 8), Zhangmen章門(LR13), Qimen期門 (LR14). Subjects in Group B will receive 14 needles based on the TCM theory "Soothing liver-qi stagnation" and "Tonifying the heart and the spleen"and "Invigorating the Yang Qi", all needles will be retained for 30 minutes. Acupoint combination: Taichong太衝 (LR 3), , Sanyinjiao 三陰交 (SP 6), Xuanzhong懸鐘 (GB 39), Shenmen 神門 (HT 7), Zusanli 足三里(ST 36), Baihui 百會(DU 20), Shenting神庭(DU24), Qihai 氣海(RN6), Guanyuan 關元(RN4). Teding Diancibo Pu (abbreviation: TDP) "特定電磁波譜" will be applied to Group B immediately after the needle insertion. This TDP device is a infra-red heat lamp which is commonly used by acupuncturists and Chinese Medicine Practitioner as a therapeutic substitute for moxibustion. The procedure will be lasted for 30 minutes in 30-40 cm above the specified acupoint Qihai 氣海(RN6) and Guanyuan 關元(RN4).

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• Change of Brain activation hemodynamic signals in 6 acupuncture sessions (concentration level of Oxygenated Hemoglobin (O2Hb) over the left dorsolateral prefrontal cortex (DLPFC)

  Will be measured by a customized portal fNIRS device

  5 minutes before, during and 10 minutes after the 1st and the last (6th) acupuncture treatment session.

• Change of Brain activation hemodynamic signals in 6 acupuncture sessions (Deoxygenated Hemoglobin (HHb)) over the left dorsolateral prefrontal cortex (DLPFC)

  Will be measured by a customized portal fNIRS device

  5 minutes before, during and 10 minutes after the 1st and the last (6th) acupuncture treatment session.

Secondary Outcomes (1)

• PHQ-9

  1. Screening stage; 2. Before start of 1st treatment in Week 1; 3. Immediately after the 2nd treatment in Week 3;4. 1st week, 2nd week and 4th week after the last treatment, conducted by telephone

Study Arms (2)

Acupunture group A

ACTIVE COMPARATOR

The subjects will receive acupuncture treatment twice weekly for 3 weeks (6 treatments in total) Subjects in Group A will receive 14 needles based on the TCM theory "Soothing liver-qi stagnation" , all needles will be retained for 30 minutes.

Other: Acupunture group A

Acupunture group B

ACTIVE COMPARATOR

The subjects will receive acupuncture treatment twice weekly for 3 weeks (6 treatments in total). Subjects in Group B will receive 14 needles based on the TCM theory "Soothing liver-qi stagnation" and "Tonifying the heart and the spleen"and "Invigorating the Yang Qi", all needles will be retained for 30 minutes.

Other: Acupunture group B

Interventions

Acupunture group A OTHER

Subjects in Group A will receive 14 needles based on the TCM theory "Soothing liver-qi stagnation", all needles will be retained for 30 minutes. Acupoint combination: Taichong太衝 (LR 3), Ligou蠡沟 (LR 5), Zhongdu 中都(LR6), Xiguan膝關 (LR 7), Ququan曲泉 (LR 8), Zhangmen章門(LR13), Qimen期門 (LR14).

Acupunture group A

Acupunture group B OTHER

Subjects in Group B will receive 14 needles based on the TCM theory "Soothing liver-qi stagnation" and "Tonifying the heart and the spleen"and "Invigorating the Yang Qi", all needles will be retained for 30 minutes. Acupoint combination: Taichong太衝 (LR 3), , Sanyinjiao 三陰交 (SP 6), Xuanzhong懸鐘 (GB 39), Shenmen 神門 (HT 7), Zusanli 足三里(ST 36), Baihui 百會(DU 20), Shenting神庭(DU24), Qihai 氣海(RN6), Guanyuan 關元(RN4). Teding Diancibo Pu (abbreviation: TDP) "特定電磁波譜" will be applied to Group B immediately after the needle insertion.

Acupunture group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65;
• Primary diagnosis as moderate and moderate severe depression;
• Patient Health Questionnaire Depression Self-test (PHQ-9) score 10-19.

You may not qualify if:

• Patients with primary diagnosis as Major Depressive Disorder, any history of psychosis or mania.
• Conditions that may make it difficult to conclusively determine that depressive symptoms are the result of Depression and not some other condition: any form of substance abuse or dependence within the last 6 months, relevant medical conditions that may be the medical basis of a depression including epilepsy, history of an abnormal EEG, severe head trauma, or stroke.
• Serious uncontrolled medical conditions \[e.g. poorly controlled diabetes, severe congestive heart failure\], or other medical conditions that have not been stable for at least 3 months;
• Received Electroconvulsive therapy (ECT) in the past year.
• Current active suicidal or self-injurious potential necessitating immediate treatment
• Pregnant

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

School of Chinese Medicine, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jun mei Wu

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun mei Wu

CONTACT

852-25890447; wujunmei@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 17, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)