DystoniaNCT03223623
Pathophysiology of Focal Hand Dystonia
A study testing TMS, MRI and VASO Imaging in people with Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Little is known about the problems in brain function in focal hand dystonia (FHD) or complex regional pain syndrome (CRPS) dystonia. It is unclear why some CRPS patients develop dystonia but others do not. Researchers want to learn which area of the brain is involved in CRPS dystonia compared with FHD. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dystonia
- What is being tested?
- TMS, MRI and VASO Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2017to 18 May 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy research volunteers and adult patients with FHD will be eligible for the study.
- Age between 18 - 70 years.
- Able to give informed consent.
- Able to comply with all study procedures.
- Subjects must be willing to abstain from alcohol for at least 48 hours prior to the study.
- Adult patients with an established diagnosis of FHD.
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- Healthy volunteers will be healthy subjects without neurological or psychiatric disorders established by history and physical/neurological examination.
- Patients receiving botulinum toxin injections will be evaluated after 3 months since their last injection.
- All participants must be able to obtain an MRI (No contraindications per MRI safety checklist) which will be part of the initial evaluation.
Who cannot join
- Self-reported consumption of >14 alcoholic drinks/week for a man and >7 alcoholic drinks/week for a woman.
- Patients on daily chronic opioid or benzodiazepine use.
- Patients treated with anticholinergics, who are not willing and/or unable to withhold taking them for 1 week prior and for the duration of the study participation.
- Patients taking opioids and/or benzodiazepines on an as needed basis, who are not willing and/or unable to withhold taking them for 1 week or time interval equivalent to 5 half-lives (whichever is shorter) prior to study participation and for the days during study participation.
- Abnormal findings on neurological examination including cognitive impairment, except diagnosis of FHD in patients.
- History of or current brain tumor, stroke, head trauma with loss of consciousness, epilepsy or seizures.
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- Past or present medical history of (a) neurological disorders, such as stroke, movement disorders (other than dystonia in the patient group), ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug dependence; (B) ventricular arrhythmias, renal and hepatic insufficiency, vascular headache, or carcinoid syndrome.
- Subjects with Baclofen pumps and/or neuro stimulators for pain.
- Current episode of major depression or any major psychiatric illness. Note: SSRI use is not exclusionary.
- Pregnant or breastfeeding women. Aside from history obtained at the screening, pregnancy status in women with childbearing potential is also established by urine pregnancy testing no more than 24 hours before each MRI and TMS sessions.
- Subjects who have contraindications to MRI:
- You have metal in your body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if you were a welder or metal worker, since you may small metal fragments in the eye.
- You are uncomfortable in small closed spaces (you have claustrophobia) so that you would feel uncomfortable in the MRI machine.
- You are not able to lie comfortably on your back for approximately 2 hours.
- Subjects who have contra-indications for TMS
- You have a pacemaker, implanted pump, stimulator, cochlear implant or metal objects inside the eye or skull.
- You have hearing loss (assessed by participant self-report or history).
- You are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Investigations of Pathophysiology of Focal Hand Dystonia
Background:
Little is known about the problems in brain function in focal hand dystonia (FHD) or complex regional pain syndrome (CRPS) dystonia. It is unclear why some CRPS patients develop dystonia but others do not. Researchers want to learn which area of the brain is involved in CRPS dystonia compared with FHD.
Read more
Objectives:
To understand why people with CRPS develop dystonia, and if these reasons are different in people with FHD.
Eligibility:
Adults ages 18 - 70 with CRPS dystonia OR with CRPS without dystonia OR with FHD and Healthy volunteers of similar age.
Design:
Participants will be screened with physical exam, neurological exam, and medical history. They may give a urine sample and will answer questions.
Participants can have 4 - 5 outpatient visits or stay at the clinical center for approximately 5-6 days.
Participants will have MRI scans. They will lie on a table that slides in and out of a scanner that takes pictures of their brain. They will do small tasks or be asked to imagine things during the scanning.
Participants will have transcranial magnetic stimulation (TMS) sessions for a few hours, with breaks. A brief electrical current passing through a well insulated wire coil on the scalp creates a magnetic pulse. This affects brain activity. Participants may do small tasks during TMS.
Participants will have the electrical activity of their muscles measured during TMS sessions. Small sticky pads will be attached to their hands and arms.
Participants ability to feel 2 separate stimuli as different will be tested by using a weak electrical shock to their fingers. They will also be asked to feel small plastic domes with ridges, that may cause discomfort.
Read the detailed description
Objective: detailed evaluation of pathophysiology of Focal Hand Dystonia (FHD) with focus on the involvement of the parietal area, and to investigate differences in cortical mapping in the sensory and motor cortices between FHD and healthy volunteers.
Study population: The study will enroll patients with FHD and Healthy Volunteers (HVs).
Design: Prospective study using MRI and Physiology experiments using EMG and TMS based protocols to evaluate the differences between the groups.
Outcome measures: The evaluation using fMRI will be performed under 3 conditions; 1. Rest 2. Voluntary activity 3. Motor imagery task.
Outcome measures (fMRI based):
We will explore the differences in BOLD signal in the parietal lobe, in FHD compared to HVs, in the different conditions. We will look for changes in the BOLD signal in the parietal sensorimotor integration area.
We will use vascular occupancy imaging (VASO) to explore differences of detailed cortical mapping of neural structures between FHD and healthy volunteers.
The Physiology experiments aim to explore abnormalities and differences in the baseline motor cortical excitability between the groups and evaluate the influence of continuous Theta Burst Stimulation (cTBS) on these measures. We will study the influence of cTBS on the phenomenon Cortical Silent Period (cSP) in FHD.
We will also be studying the baseline Spatial and Temporal Discrimination (SDTs and TDTs), which are measures of sensory surround inhibition and have been noted to be endophenotypic of dystonia.
Physiology outcomes:
Baseline differential influences of PMv and IPL on motor cortical excitability and changes after cTBS of dIPL.
Baseline cortical Silent Period (cSP) in the involved and uninvolved limb in FHD and the influence of cTBS on cSP in the involved limb.
The TDTs/ SDTs in both the involved and uninvolved limbs in FHD compared to HVs.
- Conditions
- Dystonia
- Being tested
- TMS, MRI, VASO Imaging
- Keywords
- Dystonia
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Single pulse TMS, IPL-M1 Interaction, IPL-M1 Interaction, Inhibitory Theta Burst Protocol (cTBS)
MRIDevice
High-resolution MRI for anatomical reference; fMRI scan as per research fMRI protocol will be conducted under 3 conditions. 1. Rest 2. Voluntary activity 3. Motor imagery task.
VASO ImagingDevice
The voluntary activity condition will involve 4 tasks: a. individual tapping of two fingers (index and little), b. individual tapping of four fingers (index, middle, ring, and little; no thumb) interspaced with rest periods, c. individual tapping of all five fingers (index, middle, ring, little, and thumb) interspaced with rest periods and d. Alternating grasping or retraction of a rubber ball interspaced with rest periods.
| Study group | Role | What they receive |
|---|---|---|
| FHD | Active comparator | adults with Focal Hand Dystonia Receives: Device: TMS; Device: MRI; Device: VASO Imaging |
| Healthy Volunteer | Placebo comparator | adult healthy volunteers Receives: Device: TMS; Device: MRI; Device: VASO Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
explore the differences in BOLD signal in the parietal lobe, in FHD compared to HVs, in the different conditions.
We will look for changes in the BOLD signal in the parietal sensorimotor integration area.
Measured: throughout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start12 Dec 2017
- Primary completion18 May 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223623
- Sponsor's protocol ID
- 170126
- Other IDs
- 17-N-0126
- Status last verified
- 25 May 2022
- First submitted
- 19 Jul 2017
- Last updated
- 1 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: .The anatomical MRI images obtained under this protocol will be made available to other NIH investigators on PACS (radlite.cc.nih.gov) or the NMR (oxygen.nimh.nih.gov) data server for sharing with other NIH protocols immediately after acquisition. @@@@@@All de-identified data will be shared at the time of publication or later using the NINDS data repository (data.ninds.nih.gov). Data that may be shared with investigators outside NIH will be reported at the time of Continuing Review. Submissions to NIH-sponsored or supported databases and repositories will be reported at the time of Continuing Review. Submission to non-NIH sponsored or supported databases and repositories will be submitted for prospective IRB approval.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations of Pathophysiology of Focal Hand Dystonia
- ClinicalTrials.gov ID
- NCT03223623
- Acronym / sponsor ID
- 170126
- Conditions
- Dystonia
- Keywords
- Dystonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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.
Background:
Little is known about the problems in brain function in focal hand dystonia (FHD) or complex regional pain syndrome (CRPS) dystonia. It is unclear why some CRPS patients develop dystonia but others do not. Researchers want to learn which area of the brain is involved in CRPS dystonia compared with FHD.
Objectives:
To understand why people with CRPS develop dystonia, and if these reasons are different in people with FHD.
Eligibility:
Adults ages 18 - 70 with CRPS dystonia OR with CRPS without dystonia OR with FHD and Healthy volunteers of similar age.
Design:
Participants will be screened with physical exam, neurological exam, and medical history. They may give a urine sample and will answer questions.
Participants can have 4 - 5 outpatient visits or stay at the clinical center for approximately 5-6 days.
Participants will have MRI scans. They will lie on a table that slides in and out of a scanner that takes pictures of their brain. They will do small tasks or be asked to imagine things during the scanning.
Participants will have transcranial magnetic stimulation (TMS) sessions for a few hours, with breaks. A brief electrical current passing through a well insulated wire coil on the scalp creates a magnetic pulse. This affects brain activity. Participants may do small tasks during TMS.
Participants will have the electrical activity of their muscles measured during TMS sessions. Small sticky pads will be attached to their hands and arms.
Participants ability to feel 2 separate stimuli as different will be tested by using a weak electrical shock to their fingers. They will also be asked to feel small plastic domes with ridges, that may cause discomfort.
Detailed description
Objective: detailed evaluation of pathophysiology of Focal Hand Dystonia (FHD) with focus on the involvement of the parietal area, and to investigate differences in cortical mapping in the sensory and motor cortices between FHD and healthy volunteers.
Study population: The study will enroll patients with FHD and Healthy Volunteers (HVs).
Design: Prospective study using MRI and Physiology experiments using EMG and TMS based protocols to evaluate the differences between the groups.
Outcome measures: The evaluation using fMRI will be performed under 3 conditions; 1. Rest 2. Voluntary activity 3. Motor imagery task.
Outcome measures (fMRI based):
We will explore the differences in BOLD signal in the parietal lobe, in FHD compared to HVs, in the different conditions. We will look for changes in the BOLD signal in the parietal sensorimotor integration area.
We will use vascular occupancy imaging (VASO) to explore differences of detailed cortical mapping of neural structures between FHD and healthy volunteers.
The Physiology experiments aim to explore abnormalities and differences in the baseline motor cortical excitability between the groups and evaluate the influence of continuous Theta Burst Stimulation (cTBS) on these measures. We will study the influence of cTBS on the phenomenon Cortical Silent Period (cSP) in FHD.
We will also be studying the baseline Spatial and Temporal Discrimination (SDTs and TDTs), which are measures of sensory surround inhibition and have been noted to be endophenotypic of dystonia.
Physiology outcomes:
Baseline differential influences of PMv and IPL on motor cortical excitability and changes after cTBS of dIPL.
Baseline cortical Silent Period (cSP) in the involved and uninvolved limb in FHD and the influence of cTBS on cSP in the involved limb.
The TDTs/ SDTs in both the involved and uninvolved limbs in FHD compared to HVs.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FHD | Active comparator | Device: TMS, Device: MRI, Device: VASO Imagingadults with Focal Hand Dystonia |
| Healthy Volunteer | Placebo comparator | Device: TMS, Device: MRI, Device: VASO Imagingadult healthy volunteers |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy research volunteers and adult patients with FHD will be eligible for the study.
- Age between 18 - 70 years.
- Able to give informed consent.
- Able to comply with all study procedures.
- Subjects must be willing to abstain from alcohol for at least 48 hours prior to the study.
Key exclusion criteria (18 listed)
- Self-reported consumption of >14 alcoholic drinks/week for a man and >7 alcoholic drinks/week for a woman.
- Patients on daily chronic opioid or benzodiazepine use.
- Patients treated with anticholinergics, who are not willing and/or unable to withhold taking them for 1 week prior and for the duration of the study participation.
- Patients taking opioids and/or benzodiazepines on an as needed basis, who are not willing and/or unable to withhold taking them for 1 week or time interval equivalent to 5 half-lives (whichever is shorter) prior to study participation and for the days during study participation.
- Abnormal findings on neurological examination including cognitive impairment, except diagnosis of FHD in patients.
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 |
|---|---|---|
| TMSSingle pulse TMS, IPL-M1 Interaction, IPL-M1 Interaction, Inhibitory Theta Burst Protocol (cTBS) | Device | FHD, Healthy Volunteer |
| MRIHigh-resolution MRI for anatomical reference; fMRI scan as per research fMRI protocol will be conducted under 3 conditions. 1. Rest 2. Voluntary activity 3. Motor imagery task. | Device | FHD, Healthy Volunteer |
| VASO ImagingThe voluntary activity condition will involve 4 tasks: a. individual tapping of two fingers (index and little), b. individual tapping of four fingers (index, middle, ring, and little; no thumb) interspaced with rest periods, c. individual tapping of all five fingers (index, middle, ring, little, and thumb) interspaced with rest periods and d. Alternating grasping or retraction of a rubber ball interspaced with rest periods. | Device | FHD, Healthy Volunteer |
Primary outcome
explore the differences in BOLD signal in the parietal lobe, in FHD compared to HVs, in the different conditions.
Time frame: throughout
We will look for changes in the BOLD signal in the parietal sensorimotor integration area.
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 1 Jul 2022.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. .The anatomical MRI images obtained under this protocol will be made available to other NIH investigators on PACS (radlite.cc.nih.gov) or the NMR (oxygen.nimh.nih.gov) data server for sharing with other NIH protocols immediately after acquisition. @@@@@@All de-identified data will be shared at the time of publication or later using the NINDS data repository (data.ninds.nih.gov). Data that may be shared with investigators outside NIH will be reported at the time of Continuing Review. Submissions to NIH-sponsored or supported databases and repositories will be reported at the time of Continuing Review. Submission to non-NIH sponsored or supported databases and repositories will be submitted for prospective IRB approval.
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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.
Mark Hallett, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS, MRI and VASO Imaging in people with Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 9 inclusion and 18 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 1 Jul 2022. 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. 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?
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?
explore the differences in BOLD signal in the parietal lobe, in FHD compared to HVs, in the different conditions. (time frame: throughout). 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 1 Jul 2022.