DYT-1NCT01435681
Can Short Latency Afferent Inhibition Give us Clues to Better DYT 1 Dystonia Treatments?
An observational study of DYT-1 and DYT1, run by University of Florida at 1 site in United States.
Trial summary
This is a research study using transcranial magnetic stimulation (TMS) to investigate interactions between the sensory system and the motor cortex in primary generalized dystonia (DYT1 dystonia) subjects who undergo deep brain stimulation (DBS) surgery. Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Aug 2016
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects scheduled to undergo pallidal deep brain stimulation surgery for DYT1 dystonia will be enrolled up to 12 months for this pilot trial. Genetic test results confirming DYT1 gene mutation will be reviewed prior to consenting research subjects. Patients who are diagnosed with DYT1 dystonia and are candidates for DBS surgery will be indentified as candidates for the research study. Additionally, subjects who have already undergone DBS surgery will be identified as candidates.
Who may be able to join
- Between the ages of 10 and 80 years. (CONTROL SUBJECTS between 18-80 years)
- Diagnosis and genetic test results confirming diagnosis of DYT1 dystonia.
- Currently treated with medications and enrolled in evaluation process for DBS surgery to confirm candidacy - OR -
- Previous DBS surgery
Who cannot join
- Implanted pacemaker, medication pump, vagal stimulator, Transcutaneous electrical nerve stimulation (TENS) unit or ventriculoperitoneal shunt.
- Family or personal history of medication refractory epilepsy.
- Pregnancy: due to the frequent visits over a prolonged period and the lack of Information on the safety of TMS during pregnancy, pregnant women will not be eligible to participate in this study. Women of childbearing potential will be eligible to participate, provided that they are using adequate contraception during TMS treatments.
- This study is accepting healthy volunteers, aged 18-80, as control subjects. Control subjects will not undergo DBS surgery.
- EXCLUSION CRITERIA (as it applies to healthy control subjects):
- Cannot have family history or personal history of medication refractory epilepsy
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32607
About this study
Official title: Can Short Latency Afferent Inhibition Give us Clues to Better Dystonia Treatments?
This is a research study using transcranial magnetic stimulation (TMS) to investigate interactions between the sensory system and the motor cortex in primary generalized dystonia (DYT1 dystonia) subjects who undergo deep brain stimulation (DBS) surgery.
The sensory system is the body's sense organs - smell, sight, sound, etc. - and the motor cortex is the part of your brain where nerve impulses control voluntary muscle activity.
Read the detailed description
The cause of DYT1 dystonia is not clear. DYT1 dystonia symptoms include abnormal posture or repetitive twisting movements affecting one body part; in some patients, the entire body can twist and contort painfully. Magnetic resonance imaging (MRI) studies are normally used to evaluate changes in brain structure in DYT1 dystonia. Transcranial magnetic stimulation (TMS) is a painless, non-invasive method to test how your brain conducts electrical messages to the rest of your body, including your muscles.
If you are a DYT1 dystonia patient, then this study involves up to three visits. The first visit (before DBS surgery) will last about 4 hours and the second and third visits (after DBS surgery) will last about 4 hours as well. These visits will include a complete physical and neurological exam, video recorded dystonia and mood rating scales, followed by electromyography (EMG) and TMS sessions. Subjects who have already undergone DBS surgery may participate in applicable visits based on the length of time since their DBS surgery.
If you are a control subject, this study involves one visit, about 4 hours long. This visit will include TMS and EMG sessions.
- Keywords
- DYT-1, DYT1, DYT 1, dystonia, DBS, deep brain stimulation, TMS, transcranial magnetic stimulation
- Medical subject headings
- Dystonia musculorum deformans type 1, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DYT-1 Postive | This group includes those participants who enroll having a genetically confirmed primary generalized dystonia diagnosis. | |
| Control | This group includes healthy subjects between the ages of 18 and 80. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in amplitude, at 3 and 6+ months, of motor evoked potentials (MEPs) with median nerve stimulation (SAI) and simultaneous median nerve and ulnar nerve stimulation (SAIdualstim)
Surface electromyography (EMG) will be recorded from the first dorsal interosseous muscle to determine the amplitude of potentials evoked in two ways - SAI and SAIdualstim. For SAI, potentials will be evoked with median nerve stimulation preceding TMS by the N20 latency plus 3 ms. For SAI dualstim, simultaneous stimulation of median and ulnar nerves will precede TMS by the N20 latency plus 3 ms.
Measured: 3 and 6+ months post-DBS surgery
Secondary outcomes (1)
Correlation of change in evoked potential amplitudes and clinical measures at 3 and 6+ months
The changes, from baseline to 3 and 6+ months post-operation, in amplitudes recorded during SAI and SAIdualstim testing will will be correlated with the changes in the clinical measures taken at the same timepoints. The Spearman correlation test will be used for this analysis.
Measured: 3- and 6+-months post-DBS surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startMay 2012
- Primary completionOct 2014
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DYT-1Studies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Brain and Spinal Cord Injury Research Trust Fund
- Responsible party
- Sponsor
- Investigators
- Aparna Wagle Shukla, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435681
- Sponsor's protocol ID
- 405-2011
- Status last verified
- Sep 2016
- First submitted
- 14 Sep 2011
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Short Latency Afferent Inhibition Give us Clues to Better Dystonia Treatments?
- ClinicalTrials.gov ID
- NCT01435681
- Acronym / sponsor ID
- 405-2011
- Keywords
- DYT-1, DYT1, DYT 1, dystonia, DBS, deep brain stimulation, TMS, transcranial magnetic stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Brain and Spinal Cord Injury Research Trust Fund
- Study start
- May 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 19 Sep 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 is a research study using transcranial magnetic stimulation (TMS) to investigate interactions between the sensory system and the motor cortex in primary generalized dystonia (DYT1 dystonia) subjects who undergo deep brain stimulation (DBS) surgery.
The sensory system is the body's sense organs - smell, sight, sound, etc. - and the motor cortex is the part of your brain where nerve impulses control voluntary muscle activity.
Detailed description
The cause of DYT1 dystonia is not clear. DYT1 dystonia symptoms include abnormal posture or repetitive twisting movements affecting one body part; in some patients, the entire body can twist and contort painfully. Magnetic resonance imaging (MRI) studies are normally used to evaluate changes in brain structure in DYT1 dystonia. Transcranial magnetic stimulation (TMS) is a painless, non-invasive method to test how your brain conducts electrical messages to the rest of your body, including your muscles.
If you are a DYT1 dystonia patient, then this study involves up to three visits. The first visit (before DBS surgery) will last about 4 hours and the second and third visits (after DBS surgery) will last about 4 hours as well. These visits will include a complete physical and neurological exam, video recorded dystonia and mood rating scales, followed by electromyography (EMG) and TMS sessions. Subjects who have already undergone DBS surgery may participate in applicable visits based on the length of time since their DBS surgery.
If you are a control subject, this study involves one visit, about 4 hours long. This visit will include TMS and EMG sessions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DYT-1 Postive | – | –This group includes those participants who enroll having a genetically confirmed primary generalized dystonia diagnosis. |
| Control | – | –This group includes healthy subjects between the ages of 18 and 80. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects scheduled to undergo pallidal deep brain stimulation surgery for DYT1 dystonia will be enrolled up to 12 months for this pilot trial. Genetic test results confirming DYT1 gene mutation will be reviewed prior to consenting research subjects. Patients who are diagnosed with DYT1 dystonia and are candidates for DBS surgery will be indentified as candidates for the research study. Additionally, subjects who have already undergone DBS surgery will be identified as candidates.
Key inclusion criteria (4 listed)
- Between the ages of 10 and 80 years. (CONTROL SUBJECTS between 18-80 years)
- Diagnosis and genetic test results confirming diagnosis of DYT1 dystonia.
- Currently treated with medications and enrolled in evaluation process for DBS surgery to confirm candidacy - OR -
- Previous DBS surgery
Key exclusion criteria (6 listed)
- Implanted pacemaker, medication pump, vagal stimulator, Transcutaneous electrical nerve stimulation (TENS) unit or ventriculoperitoneal shunt.
- Family or personal history of medication refractory epilepsy.
- Pregnancy: due to the frequent visits over a prolonged period and the lack of Information on the safety of TMS during pregnancy, pregnant women will not be eligible to participate in this study. Women of childbearing potential will be eligible to participate, provided that they are using adequate contraception during TMS treatments.
- This study is accepting healthy volunteers, aged 18-80, as control subjects. Control subjects will not undergo DBS surgery.
- Cannot have family history or personal history of medication refractory epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in amplitude, at 3 and 6+ months, of motor evoked potentials (MEPs) with median nerve stimulation (SAI) and simultaneous median nerve and ulnar nerve stimulation (SAIdualstim)
Time frame: 3 and 6+ months post-DBS surgery
Surface electromyography (EMG) will be recorded from the first dorsal interosseous muscle to determine the amplitude of potentials evoked in two ways - SAI and SAIdualstim. For SAI, potentials will be evoked with median nerve stimulation preceding TMS by the N20 latency plus 3 ms. For SAI dualstim, simultaneous stimulation of median and ulnar nerves will precede TMS by the N20 latency plus 3 ms.
1 secondary outcome
Correlation of change in evoked potential amplitudes and clinical measures at 3 and 6+ months
Time frame: 3- and 6+-months post-DBS surgery
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 8 Sep 2016.
- UF Center for Movement Disorders \& NeurorestorationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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.
Aparna Wagle Shukla, M.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DYT-1 and DYT1, run by University of Florida 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 4 inclusion and 6 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 8 Sep 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 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.
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 amplitude, at 3 and 6+ months, of motor evoked potentials (MEPs) with median nerve stimulation (SAI) and simultaneous median nerve and ulnar nerve stimulation (SAIdualstim) (time frame: 3 and 6+ months post-DBS surgery). 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 8 Sep 2016.