NCT01773291

Brief Summary

The purpose of this study is to determine the therapeutic effect of acupuncture on severe head injury under conventional treatment. A double-blind clinical trial is conducted up to 6 weeks and the change of subjects' Glasgow coma scale (GCS) and muscle power is measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

November 2, 2015

Completed
Last Updated

January 28, 2016

Status Verified

July 1, 2015

Enrollment Period

2.5 years

First QC Date

January 11, 2013

Results QC Date

August 25, 2015

Last Update Submit

December 22, 2015

Conditions

Head Injury

Keywords

Acupuncture; laser acupuncture; traumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • Glasgow Coma Scale (GCS)

    Eye response (E) There are four grades starting with the most severe: 1. No eye opening 2. Eye opening in response to pain stimulus. 3. Eye opening to speech. 4. Eyes opening spontaneously Verbal response (V) There are five grades starting with the most severe: 1. No verbal response 2. Incomprehensible sounds. 3. Inappropriate words. 4. Confused. 5. Oriented. Motor response (M) There are six grades: 1. No motor response 2. Decerebrate posturing accentuated by pain 3. Decorticate posturing accentuated by pain 4. Withdrawal from pain 5. Localizes to pain 6. Obeys commands The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome.

    6 weeks

Secondary Outcomes (1)

  • Muscle Power (MP)

    6 weeks

Study Arms (3)

acupuncture

EXPERIMENTAL

acupuncture on GV26 and 12 Well points

Other: acupuncture

laser acupuncture

EXPERIMENTAL

laser acupuncture on GV26 and 12 Well points

Other: laser acupuncture

control group

SHAM COMPARATOR

laser acupuncture without laser output in control group.

Other: control

Interventions

acupunctureOTHER

acupuncture on GV26 and 12 Well points

acupuncture
laser acupunctureOTHER

laser acupuncture on GV26 and 12 Well points

laser acupuncture
controlOTHER

sham laser acupuncture

control group

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less)
  • with informed consent

You may not qualify if:

  • dilated pupils without light reflex
  • serious complications during therapeutic course
  • interruption of therapeutic course
  • unfavored condition assessed by physician in charge
  • without informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Related Publications (3)

  • DeFina PA, Fellus J, Thompson JW, Eller M, Moser RS, Frisina PG, Schatz P, Deluca J, Zigarelli-McNish M, Prestigiacomo CJ. Improving outcomes of severe disorders of consciousness. Restor Neurol Neurosci. 2010;28(6):769-80. doi: 10.3233/RNN-2010-0548.

    PMID: 21209492BACKGROUND

  • Jennett B, Adams JH, Murray LS, Graham DI. Neuropathology in vegetative and severely disabled patients after head injury. Neurology. 2001 Feb 27;56(4):486-90. doi: 10.1212/wnl.56.4.486.

    PMID: 11222792BACKGROUND

  • Clauss R, Nel W. Drug induced arousal from the permanent vegetative state. NeuroRehabilitation. 2006;21(1):23-8.

    PMID: 16720934RESULT

Related Links

MeSH Terms

Conditions

Craniocerebral TraumaBrain Injuries, Traumatic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain InjuriesBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Limitations and Caveats

Inclusion criteria leading to small numbers (24/583 in 2.5 years) of subjects analyzed.

Results Point of Contact

Title
Wen-Long Hu, Deputy Director, Department of Chinese Medicine
Organization
Kaohsiung Chang Gung Memorial Hospital
oolonghu@gmail.com
+886-7-7317123

Study Officials

  • Wen-Long Hu, MS

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

January 11, 2013

First Posted

January 23, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 28, 2016

Results First Posted

November 2, 2015

Record last verified: 2015-07

Locations

TW(1)