Healthy VolunteersBANSNCT01079689
Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation
A study testing needle stimulation in people with Healthy Volunteers, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate effects on the brain after complex somatosensory stimulation with acupuncture needle. EEG and fMRI measurements will be performed. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- needle stimulation
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects of age from 18 to 40 years (inclusive)
- right-handed (evaluated by "The Edinburgh Inventory")
- with informed consent signed
- no acupuncture treatment in the last 12 months
- no medical knowledge about acupuncture
- free time to take part in the measurements
Who cannot join
- history of neurological and/or psychiatric diseases
- history of brain injury
- cognitive handicap, severe speech disorder, alcohol or drug abuse
- history of neurosurgical intervention
- chronic disease (e.g., asthma, diabetes mellitus etc.) with regular use of medications
- pregnancy (tested by urine pregnancy test before the measurement) or planned pregnancy
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- any contraindication for acupuncture (e.g., anti-coagulation therapy)
- Additional exclusion criteria for fMRI measurement:
- any contraindication for MRI (e.g., pacemaker, claustrophobia, cochlear implant, metallic implants etc. )
Trial locations and contacts
1 site in 1 country.
Germany1 site
Max Planck Institute for Human Cognitive and Brain Sciences
Leipzig, Leipzig, 04103
About this study
Official title: Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation With Acupuncture Needles
The purpose of this study is to evaluate effects on the brain after complex somatosensory stimulation with acupuncture needle. EEG and fMRI measurements will be performed.
Read the detailed description
The aim of the study is to evaluate whether the point locations chosen for a complex somatosensory stimulation with acupuncture needles have an essential impact on the change of brain activity in healthy volunteers. For this, the investigators compare three different point locations (one acupuncture point and two non-acupuncture points) stimulated with acupuncture needles. Two measurements each with 20 subjects are planned.
- With the EEG measurements the impact of the stimulation's location on background rhythm especially in the somatosensoric cortex is evaluated.
- With the fMRI (functional magnetic resonance imaging) measurements the impact of the stimulation's location on BOLD (Blood Oxygen Level Dependency) signals and on functional connectivity is evaluated.
- Conditions
- Healthy Volunteers
- Being tested
- needle stimulation
- Keywords
- basic science, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
needle stimulationOther
stimulation with acupuncture needles
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain background rhythms after stimulation (baseline vs. post stimulation) in comparison between the three different point locations.
Measured: 26 minutes
Changes in resting state functional connectivity after stimulation (baseline vs. post-stimulation) in comparison between the three different point locations
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Max Planck Institute for Human Cognitive and Brain Sciences, Berlin
- Responsible party
- Principal investigator, Claudia M. Witt, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079689
- Sponsor's protocol ID
- BANS10
- Acronym
- BANS
- Status last verified
- Jul 2012
- First submitted
- 2 Mar 2010
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Long X, Huang W, Napadow V, Liang F, Pleger B, Villringer A, Witt CM, Nierhaus T, Pach D. Sustained Effects of Acupuncture Stimulation Investigated with Centrality Mapping Analysis. Front Hum Neurosci. 2016 Oct 18;10:510. doi: 10.3389/fnhum.2016.00510. eCollection 2016.
PubMed 27803655
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation With Acupuncture Needles
- ClinicalTrials.gov ID
- NCT01079689
- Acronym / sponsor ID
- BANS / BANS10
- Conditions
- Healthy Volunteers
- Keywords
- basic science, healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Max Planck Institute for Human Cognitive and Brain Sciences, Berlin
- Study start
- Feb 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Not posted in the source record
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 evaluate effects on the brain after complex somatosensory stimulation with acupuncture needle. EEG and fMRI measurements will be performed.
Detailed description
The aim of the study is to evaluate whether the point locations chosen for a complex somatosensory stimulation with acupuncture needles have an essential impact on the change of brain activity in healthy volunteers. For this, the investigators compare three different point locations (one acupuncture point and two non-acupuncture points) stimulated with acupuncture needles. Two measurements each with 20 subjects are planned.
- With the EEG measurements the impact of the stimulation's location on background rhythm especially in the somatosensoric cortex is evaluated.
- With the fMRI (functional magnetic resonance imaging) measurements the impact of the stimulation's location on BOLD (Blood Oxygen Level Dependency) signals and on functional connectivity is evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy subjects of age from 18 to 40 years (inclusive)
- right-handed (evaluated by "The Edinburgh Inventory")
- with informed consent signed
- no acupuncture treatment in the last 12 months
- no medical knowledge about acupuncture
Key exclusion criteria (9 listed)
- history of neurological and/or psychiatric diseases
- history of brain injury
- cognitive handicap, severe speech disorder, alcohol or drug abuse
- history of neurosurgical intervention
- chronic disease (e.g., asthma, diabetes mellitus etc.) with regular use of medications
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 |
|---|---|---|
| needle stimulationstimulation with acupuncture needles | Other | – |
Primary outcome
Change in brain background rhythms after stimulation (baseline vs. post stimulation) in comparison between the three different point locations.
Time frame: 26 minutes
Changes in resting state functional connectivity after stimulation (baseline vs. post-stimulation) in comparison between the three different point locations
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- Derived from this study: PubMed 27803655Long X, Huang W, Napadow V, Liang F, Pleger B, Villringer A, Witt CM, Nierhaus T, Pach D. Sustained Effects of Acupuncture Stimulation Investigated with Centrality Mapping Analysis. Front Hum Neurosci. 2016 Oct 18;10:510. doi: 10.3389/fnhum.2016.00510. eCollection 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing needle stimulation in people with Healthy Volunteers, run by Charite University, Berlin, Germany 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 6 inclusion and 9 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 10 Jul 2012. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in brain background rhythms after stimulation (baseline vs. post stimulation) in comparison between the three different point locations. (time frame: 26 minutes). The study lists 2 primary outcomes in all. 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 NCT01079689, which also lists 1 linked publication.
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 10 Jul 2012.