Head InjuryNCT01773291
Adjuvant Acupuncture for Severe Head Injury
A study testing acupuncture and laser acupuncture in people with Head Injury, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Head Injury
- What is being tested?
- acupuncture and laser acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less)
- with informed consent
Who cannot join
- dilated pupils without light reflex
- serious complications during therapeutic course
- interruption of therapeutic course
- unfavored condition assessed by physician in charge
- without informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Acupuncture Therapy in Patients With Severe Head Injury: a Randomized Controlled Trial
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.
Read the detailed description
Objective: To investigate the therapeutic effect of acupuncture on severe head injury under conventional treatment.
Methods: 90 subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less) are randomly divided into acupuncture, laser acupuncture and control group. We use restoring consciousness acupuncture (GV26 and 12 Well points) to treat the subjects 3 sessions per week under conventional treatment at Department of Neurosurgery. A double-blind clinical trial is conducted up to 6 weeks and the change of subjects' GCS and muscle power is measured.
- Conditions
- Head Injury
- Being tested
- acupuncture, laser acupuncture, control
- Keywords
- Acupuncture; laser acupuncture; traumatic brain injury
- Medical subject headings
- Craniocerebral Trauma, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
acupuncture on GV26 and 12 Well points
laser acupunctureOther
laser acupuncture on GV26 and 12 Well points
controlOther
sham laser acupuncture
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | acupuncture on GV26 and 12 Well points Receives: Other: acupuncture |
| laser acupuncture | Experimental | laser acupuncture on GV26 and 12 Well points Receives: Other: laser acupuncture |
| control group | Sham comparator | laser acupuncture without laser output in control group. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Coma Scale (GCS)
Eye response (E)
There are four grades starting with the most severe:
- No eye opening
- Eye opening in response to pain stimulus.
- Eye opening to speech.
- Eyes opening spontaneously Verbal response (V)
There are five grades starting with the most severe:
- No verbal response
- Incomprehensible sounds.
- Inappropriate words.
- Confused.
- Oriented. Motor response (M)
There are six grades:
- No motor response
- Decerebrate posturing accentuated by pain
- Decorticate posturing accentuated by pain
- Withdrawal from pain
- Localizes to pain
- Obeys commands
The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome.
Measured: 6 weeks
Secondary outcomes (1)
Muscle Power (MP)
Medical Research Council (MRC) muscle-grading scale Grade MRC grade of muscle strength 0 No movement
- Flicker of movement only
- Movement possible when assisted by gravity or gravity is eliminated
- Movement possible against gravity but without imposed resistance
- Weak movement possible against gravity
- Normal movement against gravity and against imposed resistance
The 4 muscle groups were assessed on the 0 to 5 scale and scores were summed before and after treatment during hospitalization. The total score ranges from 0-20, with higher score indicating better outcome.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Long Hu, MS, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773291
- Sponsor's protocol ID
- CMRPG8B1211
- Other IDs
- 103-5150C
- Status last verified
- Jul 2015
- First submitted
- 11 Jan 2013
- Last updated
- 28 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21209492Jennett 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.
PubMed 11222792Clauss R, Nel W. Drug induced arousal from the permanent vegetative state. NeuroRehabilitation. 2006;21(1):23-8.
PubMed 16720934
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Acupuncture Therapy in Patients With Severe Head Injury: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01773291
- Acronym / sponsor ID
- CMRPG8B1211
- Conditions
- Head Injury
- Keywords
- Acupuncture; laser acupuncture; traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Posted 2 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: To investigate the therapeutic effect of acupuncture on severe head injury under conventional treatment.
Methods: 90 subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less) are randomly divided into acupuncture, laser acupuncture and control group. We use restoring consciousness acupuncture (GV26 and 12 Well points) to treat the subjects 3 sessions per week under conventional treatment at Department of Neurosurgery. A double-blind clinical trial is conducted up to 6 weeks and the change of subjects' GCS and muscle power is measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Other: acupunctureacupuncture on GV26 and 12 Well points |
| laser acupuncture | Experimental | Other: laser acupuncturelaser acupuncture on GV26 and 12 Well points |
| control group | Sham comparator | Other: controllaser acupuncture without laser output in control group. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less)
- with informed consent
Key exclusion criteria (5 listed)
- dilated pupils without light reflex
- serious complications during therapeutic course
- interruption of therapeutic course
- unfavored condition assessed by physician in charge
- without informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureacupuncture on GV26 and 12 Well points | Other | acupuncture |
| laser acupuncturelaser acupuncture on GV26 and 12 Well points | Other | laser acupuncture |
| controlsham laser acupuncture | Other | control group |
Primary outcome
Glasgow Coma Scale (GCS)
Time frame: 6 weeks
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.
1 secondary outcome
Muscle Power (MP)
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21209492DeFina 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.
- Background: PubMed 11222792Jennett 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.
- Results publication: PubMed 16720934Clauss R, Nel W. Drug induced arousal from the permanent vegetative state. NeuroRehabilitation. 2006;21(1):23-8.
- Acupuncture for Disorders of Consciousness - A Case Series and ReviewLink provided by the sponsor.
- Efficacy of Stimulation at the Jing-Well Points of MeridiansLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Long Hu, MS principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and laser acupuncture in people with Head Injury, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Coma Scale (GCS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01773291, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.