Carpal Tunnel SyndromeEarly Phase 1NCT01345994
Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture
A Early Phase 1 study testing electro-acupuncture in people with Carpal Tunnel Syndrome, run by Martinos Center for Biomedical Imaging at 1 site in United States.
Trial summary
This study will characterize brain plasticity in Carpal Tunnel Syndrome and will determine how this central fMRI biomarker is modulated by acupuncture. This study will also investigate the behavioral consequences of maladaptive cortical plasticity in this disease population. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- electro-acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 2009to May 2013
- Phase
- Early Phase 1
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female adults aged 20-60.
- History
- Pain and/or paresthesia in median nerve distribution (i.e., numbness in some combination of digit 1, 2, 3, and the radial part of digit 4)
- Nocturnal pain and/or paresthesia in median nerve distribution
- Symptoms (a and b) greater than 3 months in duration
- Physical Exam with two of the following three findings:
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- Phalen's and Durkin's sign (positive with paresthesia in at least 1 of 3 radial digits)
- Abnormal grip strength (greater than 2 S.D. compared to uninvolved side using an isometric hand grip device)
- Nerve conduction findings consistent with mild to severe CTS:
- Mild CTS: Delayed distal latency of the sensory nerve conductions across the wrist (> 3.7milliseconds and/or > than 0.5 milliseconds compared to the ulnar sensory conduction) with normal motor conductions
- Moderate CTS: Delayed distal latency of the sensory nerve conductions across the wrist as stated above with delayed distal latency of the motor conductions across the wrist (> 4.2 milliseconds).
- Severe CTS: Delayed distal latency of the sensory nerve conductions across the wrist as stated above with greater than 50% loss of motor amplitudes (relative to unaffected side and/or normative range).
Who cannot join
- Contraindications to MRI examination (pregnancy, pacemaker, etc. according to guidelines set by MGH NMR-Center)
- History of diabetes mellitus or other major cardiovascular, respiratory, or neurological illnesses.
- History of rheumatoid arthritis.
- History of wrist fracture with direct trauma to median nerve.
- Current usage of prescriptive opioid pain medication.
- Severe thenar atrophy.
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- Nerve entrapment other than median nerve.
- Cervical radiculopathy or myelopathy.
- Generalized peripheral neuropathy.
- A blood dyscrasia or coagulopathy or current use of anticoagulation therapy
Trial locations and contacts
1 site in 1 country.
Pia Hugus contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02129
Pia Hugus, 781-391-7518 ext. 306
Vitaly Napadow, PhD
About this study
This study will characterize brain plasticity in Carpal Tunnel Syndrome and will determine how this central fMRI biomarker is modulated by acupuncture. This study will also investigate the behavioral consequences of maladaptive cortical plasticity in this disease population.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- electro-acupuncture
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electro-acupunctureProcedure or surgery
acupuncture stimulation with electricity
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture - local | Experimental | acupuncture on forearm only Receives: Procedure: electro-acupuncture |
| acupuncture - distal | Experimental | acupuncture on both arm and leg Receives: Procedure: electro-acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional MRI brain response
Several fMRI outcomes will be assessed including brain hyperactivity and somatotopy
Measured: Baseline vs. Post-Acupuncture (average 9 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startMay 2009
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies 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
- Early Phase 1
Sponsor and investigators
- Lead sponsor
- Martinos Center for Biomedical Imaging
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345994
- Sponsor's protocol ID
- AT004714
- Other IDs
- R01AT004714-01
- Status last verified
- Mar 2011
- First submitted
- 25 Apr 2011
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture
- ClinicalTrials.gov ID
- NCT01345994
- Acronym / sponsor ID
- AT004714
- Conditions
- Carpal Tunnel Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Martinos Center for Biomedical ImagingUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- May 2009
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 2 May 2011 (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.
This study will characterize brain plasticity in Carpal Tunnel Syndrome and will determine how this central fMRI biomarker is modulated by acupuncture. This study will also investigate the behavioral consequences of maladaptive cortical plasticity in this disease population.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture - local | Experimental | Procedure: electro-acupunctureacupuncture on forearm only |
| acupuncture - distal | Experimental | Procedure: electro-acupunctureacupuncture on both arm and leg |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female adults aged 20-60.
- History
- Physical Exam with two of the following three findings:
- Nerve conduction findings consistent with mild to severe CTS:
- Mild CTS: Delayed distal latency of the sensory nerve conductions across the wrist (> 3.7milliseconds and/or > than 0.5 milliseconds compared to the ulnar sensory conduction) with normal motor conductions
Key exclusion criteria (10 listed)
- Contraindications to MRI examination (pregnancy, pacemaker, etc. according to guidelines set by MGH NMR-Center)
- History of diabetes mellitus or other major cardiovascular, respiratory, or neurological illnesses.
- History of rheumatoid arthritis.
- History of wrist fracture with direct trauma to median nerve.
- Current usage of prescriptive opioid pain medication.
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 |
|---|---|---|
| electro-acupunctureacupuncture stimulation with electricity | Procedure or surgery | Acupuncture - local, acupuncture - distal |
Primary outcome
Functional MRI brain response
Time frame: Baseline vs. Post-Acupuncture (average 9 weeks later)
Several fMRI outcomes will be assessed including brain hyperactivity and somatotopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
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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.
Pia Hugus contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing electro-acupuncture in people with Carpal Tunnel Syndrome, run by Martinos Center for Biomedical Imaging at 1 site in United States.
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 12 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 May 2011. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pia Hugus (781-391-7518 ext. 306), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional MRI brain response (time frame: Baseline vs. Post-Acupuncture (average 9 weeks later)). 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 2 May 2011.