NCT06243237

Brief Summary

Investigators propose a research design protocol to evaluate the efficacy of acupuncture in improving function recovery after acute intracranial hemorrhage.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

March 5, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

June 5, 2024

Status Verified

December 1, 2023

Enrollment Period

1.7 years

First QC Date

December 19, 2023

Last Update Submit

June 3, 2024

Conditions

Intracranial Hemorrhages

Outcome Measures

Primary Outcomes (6)

  • Barthel Index

    The Barthel Index is a scale used to measure performance in activities of daily living (ADL). The total score can range from 0 (complete dependence) to 100 (complete independence), providing a quantitative measure of an individual's functional independence.

    3 weeks and follow-up for one year

  • Muscle Power

    Muscle power is often assessed using a grading system. The most common is the Medical Research Council (MRC) Scale, which grades muscle strength on a scale from 0 to 5 and the lower scores mean the worse outcome.

    3 weeks and follow-up for one year

  • The Modified Rankin Scale

    The Modified Rankin Score (mRS) is a scale with scores ranging from 0 to 6, the higher scores mean the worse outcome.

    3 weeks and follow-up for one year

  • National Institute of Health Stroke Scale

    The total NIHSS score can range from 0 to 42, where a score of 0 means no stroke symptoms, and a higher score indicates a more severe stroke.

    3 weeks and follow-up for one year

  • Glasgow Coma Scale(GCS)

    The Glasgow Coma Scale(GCS) is a clinical scale used to reliably measure a person's level of consciousness. The total score can range from 3 to 15, and the lower scores mean the worse outcome.

    3 weeks and follow-up for one year

  • Karnofsky Performance Scale

    The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death.

    3 weeks and follow-up for one year

Secondary Outcomes (9)

  • Pulse analysis system (PPAS-96)(Sphygmography)

    3 weeks and follow-up for one year

  • Completed blood count (CBC)

    3 weeks and follow-up for one year

  • White blood cells differential count

    3 weeks and follow-up for one year

  • C reactive protein (CRP)

    3 weeks and follow-up for one year

  • Albumin

    3 weeks and follow-up for one year

  • +4 more secondary outcomes

Study Arms (2)

Intervention group(acupuncture group)

EXPERIMENTAL

After blind random allocation, investigators applied acupuncture on patient with acute intracranial hemorrhage.

Procedure: Acupuncture

Control group(sham acupuncture group (superficial acupuncture))

PLACEBO COMPARATOR

After blind random allocation, investigators applied superficial acupuncture on patient with acute intracranial hemorrhage.

Procedure: Sham Acupuncture(Superficial Acupuncture)

Interventions

AcupuncturePROCEDURE

Applied acupuncture on specific acupoints in patient with acute intracranial hemorrhage.

Intervention group(acupuncture group)
Sham Acupuncture(Superficial Acupuncture)PROCEDURE

Applied superficial acupuncture on specific acupoints in patient with acute intracranial hemorrhage.

Control group(sham acupuncture group (superficial acupuncture))

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of hemorrhagic stroke by a specialist
  • Age over 20 years and below 85 years
  • GCS between 5-13

You may not qualify if:

  • Intracranial hemorrhage resulted from vascular anomalies
  • Pregnant patients
  • Intracranial tumor related hemorrhage
  • Other diseases that can cause neurological deficits, such as old cerebrovascular disease, poliomyelitis, cerebral palsy, spinal cord injury
  • Organ damage or terminal illness (heart or kidney failure or malignancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang-Gung Memorial Hospital

Keelung, Taiwan

RECRUITING

MeSH Terms

Conditions

Intracranial Hemorrhages

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Yan Ru Ko

    Chang Gung Memorial Hospital

    STUDY DIRECTOR

Central Study Contacts

Yan Ru Ko

CONTACT

886972792003b9403213@cgmh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2023

First Posted

February 6, 2024

Study Start

March 5, 2024

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

June 5, 2024

Record last verified: 2023-12

Locations

TW(1)