Evoked PotentialsNCT00333606
Acupuncture and Auditory Evoked Potentials
A study testing Acupuncture in people with Evoked Potentials and Healthy Volunteers, run by Taras Usichenko at 1 site in Germany.
Trial summary
To investigate whether body acupuncture of acupuncture points specific for hearing influences the auditory avoked potentials in comparison to puncture of non-specific acupuncture points Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Evoked Potentials, Healthy Volunteers
- What is being tested?
- Acupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2005to Mar 2009
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged 20-40 years
- Physical status I according to American Society of Anesthesiologists (ASA) classification
- No history of nervous or psychiatric disease
- Normal audiogram before the study
- No chronic consume of analgesics, anticoagulants and/or antiplatelet agents, sedatives or alcohol
- No local infection at the site of acupuncture
- Volunteers who have given informed consent
Who cannot join
- Pregnant or nursing females.
- History of peripheral neuropathy
- Abnormal skin conditions (infection, scars, psoriasis, eczema)
- Inflamed site of acupuncture within 1 week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Acupuncture on the Auditory Evoked Potentials: a Randomized Volunteer Crossover Study
To investigate whether body acupuncture of acupuncture points specific for hearing influences the auditory avoked potentials in comparison to puncture of non-specific acupuncture points
- Conditions
- Evoked Potentials, Healthy Volunteers
- Being tested
- Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureBehavioural
Body acupuncture of 1 specific point per trial session
| Study group | Role | What they receive |
|---|---|---|
| Verum acupuncture | Experimental | Acupuncture of specific acupuncture points Receives: Behavioral: Acupuncture |
| Sham acupuncture | Sham comparator | Acupuncture of non-specific acupuncture points Receives: Behavioral: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latencies of Auditory Evoked Potentials
Measured: before acupuncture stimulation
Secondary outcomes (1)
Pain Intensity
Visual Analogue Scale 0-100 mm, where 0=no pain, and 100=maximal pain
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startJan 2005
- Primary completionFeb 2007
- Study completionMar 2009
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.
- Other trials for Evoked PotentialsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taras Usichenko
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Taras Usichenko, University Medicine Greifswald
- Investigators
- Taras I Usichenko, M.D., Study chair, Ernst Moritz Arndt UniversityReinhard Schmidt, M.D., Principal investigator, Ernst Moritz Arndt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333606
- Sponsor's protocol ID
- III UV 12/06
- Status last verified
- Apr 2017
- First submitted
- 3 Jun 2006
- Last updated
- 22 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acupuncture on the Auditory Evoked Potentials: a Randomized Volunteer Crossover Study
- ClinicalTrials.gov ID
- NCT00333606
- Acronym / sponsor ID
- III UV 12/06
- Conditions
- Evoked Potentials, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taras UsichenkoUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Jun 2006 (estimated)
- Results
- Posted 22 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether body acupuncture of acupuncture points specific for hearing influences the auditory avoked potentials in comparison to puncture of non-specific acupuncture points
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum acupuncture | Experimental | Behavioral: AcupunctureAcupuncture of specific acupuncture points |
| Sham acupuncture | Sham comparator | Behavioral: AcupunctureAcupuncture of non-specific acupuncture points |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy volunteers aged 20-40 years
- Physical status I according to American Society of Anesthesiologists (ASA) classification
- No history of nervous or psychiatric disease
- Normal audiogram before the study
- No chronic consume of analgesics, anticoagulants and/or antiplatelet agents, sedatives or alcohol
Key exclusion criteria (4 listed)
- Pregnant or nursing females.
- History of peripheral neuropathy
- Abnormal skin conditions (infection, scars, psoriasis, eczema)
- Inflamed site of acupuncture within 1 week
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 |
|---|---|---|
| AcupunctureBody acupuncture of 1 specific point per trial session | Behavioural | Sham acupuncture, Verum acupuncture |
Primary outcome
Latencies of Auditory Evoked Potentials
Time frame: before acupuncture stimulation
1 secondary outcome
Pain Intensity
Time frame: 30 min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Taras I Usichenko, M.D. study chair
Ernst Moritz Arndt University
Reinhard Schmidt, M.D. principal investigator
Ernst Moritz Arndt University
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 in people with Evoked Potentials and Healthy Volunteers, run by Taras Usichenko at 1 site in Germany.
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 7 inclusion and 4 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 22 Oct 2019. 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 Germany. 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 22 Oct 2019). 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?
Latencies of Auditory Evoked Potentials (time frame: before acupuncture stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2019.