Retinitis PigmentosaPhase 1NCT01604356
Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa
A Phase 1 study testing Electro-acupuncture in people with Retinitis Pigmentosa, run by Johns Hopkins University at 1 site in United States.
Trial summary
Retinitis Pigmentosa (RP) patients are interested in trying alternative therapies to attempt to slow, halt or reverse the retinal disease process, and claim success with some approaches such as acupuncture, but this potential treatment has not been put to the test of objective, rigorous scientific study conducted in… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Retinitis Pigmentosa
- 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
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2013
- Phase
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 10+
- Diagnosis of retinitis pigmentosa
- Best-corrected visual acuity better than 20/400 in at least one eye
- More than 20% loss of Goldmann Visual Field area (III4e) in at least one eye
- Able and willing to participate in all study visits in Baltimore for the 8-week program
- Provide informed consent
Who cannot join
- Very severe vision losses in both eyes (e.g., hand motions or light perception only) with difficulty performing the proposed vision tests
- Vision loss due to ocular diseases other than RP, cystoid macular edema, or cataracts
- Schedules do not permit participation in all study visits
- Previous acupuncture treatment in the last 6 months
- Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment)
- Dementia; Long or short-term memory loss
Show all 10Show fewer
- Unable to read or speak English
- Smoking, substance abuse, or illegal drug use
- Receiving current psychiatric care (i.e. unstable emotional and mental health status)
- History of excessive bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Retinitis Pigmentosa (RP) patients are interested in trying alternative therapies to attempt to slow, halt or reverse the retinal disease process, and claim success with some approaches such as acupuncture, but this potential treatment has not been put to the test of objective, rigorous scientific study conducted in western society. In this pilot study, the investigators aim to evaluate an acupuncture treatment tailored to the RP population for its feasibility to improve visual function, specifically visual field and dark adaptation. The study results may provide a basis for eye care providers' recommendations to RP patients regarding whether to consider acupuncture as a potential treatment modality. If our hypotheses regarding improvements in vision beyond typical test variability are supported, our future research goals include the conduct of a larger clinical trial with involving randomization and a placebo control for acupuncture in RP.
- Conditions
- Retinitis Pigmentosa
- Being tested
- Electro-acupuncture
- Keywords
- retinitis pigmentosa
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-acupunctureProcedure or surgery
Ten treatment sessions at our center during a two week period (5 sessions per week). Each session will last approximately 30 minutes. The intervention will involve the placement of acupuncture needles in a standard set of points across all patients, located on the head, around the eyes, on the abdomen, on the hands, feet, arms and legs. An electro-acupuncture device [Transcutaneous electrical nerve stimulator (TENS) unit by Lhasa OMS Inc.; model AWQ-104L] and will be used on four of the acupuncture points (two per session) located on the forehead, and side of the face/temple.
| Study group | Role | What they receive |
|---|---|---|
| Electro-acupuncture | Experimental | Not described Receives: Procedure: Electro-acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dark-adapted (Scotopic) Full-field Stimulus Test
Measured: initial response within 2 weeks after completion of treatment
Secondary outcomes (4)
Goldmann visual fields
Measured: initial response within 2 weeks of treatment completion
PC-based vision tests (visual acuity, contrast sensitivity, visual field)
Measured: initial response within 2 weeks of treatment completion
ETDRS visual acuity
Measured: initial response within 2 weeks of treatment completion
Pelli-Robson contrast sensitivity
Measured: initial response within 2 weeks of treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ava Bittner, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604356
- Sponsor's protocol ID
- NA_00050691
- Status last verified
- Mar 2014
- First submitted
- 21 May 2012
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for the Treatment of Vision Loss Due to Retinitis Pigmentosa
- ClinicalTrials.gov ID
- NCT01604356
- Acronym / sponsor ID
- NA_00050691
- Conditions
- Retinitis Pigmentosa
- Keywords
- retinitis pigmentosa
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 May 2012 (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.
Retinitis Pigmentosa (RP) patients are interested in trying alternative therapies to attempt to slow, halt or reverse the retinal disease process, and claim success with some approaches such as acupuncture, but this potential treatment has not been put to the test of objective, rigorous scientific study conducted in western society. In this pilot study, the investigators aim to evaluate an acupuncture treatment tailored to the RP population for its feasibility to improve visual function, specifically visual field and dark adaptation. The study results may provide a basis for eye care providers' recommendations to RP patients regarding whether to consider acupuncture as a potential treatment modality. If our hypotheses regarding improvements in vision beyond typical test variability are supported, our future research goals include the conduct of a larger clinical trial with involving randomization and a placebo control for acupuncture in RP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electro-acupuncture | Experimental | Procedure: Electro-acupuncture |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 10+
- Diagnosis of retinitis pigmentosa
- Best-corrected visual acuity better than 20/400 in at least one eye
- More than 20% loss of Goldmann Visual Field area (III4e) in at least one eye
- Able and willing to participate in all study visits in Baltimore for the 8-week program
Key exclusion criteria (10 listed)
- Very severe vision losses in both eyes (e.g., hand motions or light perception only) with difficulty performing the proposed vision tests
- Vision loss due to ocular diseases other than RP, cystoid macular edema, or cataracts
- Schedules do not permit participation in all study visits
- Previous acupuncture treatment in the last 6 months
- Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment)
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-acupunctureTen treatment sessions at our center during a two week period (5 sessions per week). Each session will last approximately 30 minutes. The intervention will involve the placement of acupuncture needles in a standard set of points across all patients, located on the head, around the eyes, on the abdomen, on the hands, feet, arms and legs. An electro-acupuncture device [Transcutaneous electrical nerve stimulator (TENS) unit by Lhasa OMS Inc.; model AWQ-104L] and will be used on four of the acupuncture points (two per session) located on the forehead, and side of the face/temple. | Procedure or surgery | Electro-acupuncture |
Primary outcome
Dark-adapted (Scotopic) Full-field Stimulus Test
Time frame: initial response within 2 weeks after completion of treatment
4 secondary outcomes
Goldmann visual fields
Time frame: initial response within 2 weeks of treatment completion
PC-based vision tests (visual acuity, contrast sensitivity, visual field)
Time frame: initial response within 2 weeks of treatment completion
ETDRS visual acuity
Time frame: initial response within 2 weeks of treatment completion
Pelli-Robson contrast sensitivity
Time frame: initial response within 2 weeks of treatment completion
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 4 Mar 2014.
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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 Phase 1 study testing Electro-acupuncture in people with Retinitis Pigmentosa, run by Johns Hopkins University 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 6 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: finished, as of the sponsor's last update on 4 Mar 2014. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dark-adapted (Scotopic) Full-field Stimulus Test (time frame: initial response within 2 weeks after completion of treatment). 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 4 Mar 2014.