Focal Hand DystoniaNCT00376753
Muscle Contraction in Patients With Focal Hand Dystonia
An observational study of Focal Hand Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine and compare brain activity in people with focal hand dystonia (FHD) and healthy volunteers to obtain further knowledge about the underlying cause of FHD. Patients with dystonia have muscle spasms that cause abnormal postures while trying to perform a movement; FHD affects the hands and fine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Hand Dystonia
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2006to 11 May 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PATIENTS:
- 18 years old or older
- Presence of FHD, for Experiment 5, 6, 7 and 8 the affected limb has to be the right and dominant side
- HEALTHY VOLUNTEERS:
- 18 years old or older
- Right handedness
- Absence of dystonia or other neurological disorder with any effect on the motor or sensory systems
Who cannot join
- PATIENTS AND HEALTHY VOLUNTEERS:
- Concurrent significant medical, surgical, neurological or psychiatric condition
- Taking the following medications: antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
- Patients- Received botulinum toxin injection within 3 months of starting the protocol
- For TMS: Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye
- History of seizure disorder
Show all 9Show fewer
- Known history of hearing loss
- For MRI: Presence of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, or shrapnel fragments. Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye of which they may be unaware.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: The Effect of Surround Inhibition During Phasic Compared to Tonic Voluntary Finger Movement in Focal Hand Dystonia
This study will examine and compare brain activity in people with focal hand dystonia (FHD) and healthy volunteers to obtain further knowledge about the underlying cause of FHD. Patients with dystonia have muscle spasms that cause abnormal postures while trying to perform a movement; FHD affects the hands and fine finger movements. During fine finger movement, the brain controls muscles in a process called surround inhibition. This process may be impaired in people with hand dystonia, leading to uncontrolled overactivity in muscles and impairing motor function.
Healthy volunteers and patients with FHD over 18 years of age may be eligible for this study. Candidates are screened with a physical and neurological examination.
Read more
In a series of three experiments conducted during a single clinic visit, participants undergo transcranial magnetic stimulation (TMS) while performing a finger movement. A wire coil is placed on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the outer part of the brain. The stimulation may cause muscle, hand or arm twitching, or may affect movement or reflexes. During the stimulation, the subject is asked to contract one finger.
In addition to TMS, subjects have surface electromyography. For this test, they sit in a chair with their hands placed on a pillow on their lap. The electrical activity of three muscles in the right hand is recorded by electrodes (small metal disks) taped to the skin over the muscles.
Read the detailed description
OBJECTIVE:
In sensory systems, a neural mechanism called surround inhibition (SI) sharpens sensation by creating an inhibitory zone around the central core of activation. This principle was described for the visual system first, but there is evidence for similar mechanisms in the primary motor cortex (M1) involved in movement generation and control, especially in precise motor tasks. Dystonia is generally regarded as a motor execution abnormality due to a dysfunction in the cortico-striato-thalamo-cortical motor loop. Using transcranial magnetic stimulation (TMS), recent findings point to highly task-specific impairment of motor cortical inhibition in patients with focal hand dystonia (FHD).
The goal for this research proposal is to understand the underlying physiology as it relates to different inhibitory pathways on movement generation and control. To achieve this goal, different modes of voluntary contractions will be examined in healthy controls and patients with FHD with the prospect of having new options for treatment.
STUDY POPULATION:
We intend to study 100 adult patients with FHD and 100 healthy volunteers on an outpatient basis.
DESIGN:
Participants will perform a contraction of the first dorsal interosseous muscle (FDI). At rest, before EMG-onset (premotor), during phasic and tonic contraction single TMS pulses (Experiment 1) or double TMS pulses (Experiment 2) will be applied over the primary motor cortex to assess activation-induced changes in cortical excitability in the abductor pollicis brevis muscle (APB), which is not activated. Additionally the influence of visual feedback on short intracortical inhibition (SICI) will be tested in Experiment 3. In Experiment 4-8 interhemispheric (IHI), ventral and dorso-lateral premotor-motor intracortical inhibition will be assessed.
OUTCOME MEASURES:
The primary outcome measure for Experiment 1 will be the difference in MEP peak-to-peak amplitude between all motor conditions.
The primary outcome measure for Experiment 2, 5, 6, 7 and 8 will be the difference in normalized MEP peak-to-peak amplitude between all motor conditions in FHD patients and healthy volunteers.
In Experiments 1 and 2, the change in MEP peak-to-peak amplitude between different force levels (10% versus 20%) will be a second outcome parameter.
The primary outcome parameter for Experiment 3 will be change in MEP peak-to-peak between patients and healthy volunteers during tonic contraction with and without visual feedback.
In Experiment 4, Hmax/Mmax ratio will be the primary outcome parameter.
- Conditions
- Focal Hand Dystonia
- Keywords
- Transcranial Magnetic Stimulation (TMS), Writer's Cramp, Electromyogram, Focal Hand Dystonia, FHD, Healthy Volunteer, HV
- Medical subject headings
- Dystonia, Focal, Task-Specific, Dystonic Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
- Study start11 Sep 2006
- Study completion11 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Focal Hand 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
- Observational
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376753
- Sponsor's protocol ID
- 060242
- Other IDs
- 06-N-0242
- Status last verified
- 11 May 2011
- First submitted
- 14 Sep 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Berardelli A, Rothwell JC, Hallett M, Thompson PD, Manfredi M, Marsden CD. The pathophysiology of primary dystonia. Brain. 1998 Jul;121 ( Pt 7):1195-212. doi: 10.1093/brain/121.7.1195.
PubMed 9679773Bressman SB, de Leon D, Raymond D, Greene PE, Brin MF, Fahn S, Ozelius LJ, Breakefield XO, Kramer PL, Risch NJ. The role of the DYT1 gene in secondary dystonia. Adv Neurol. 1998;78:107-15. No abstract available.
PubMed 9750907Defazio G, Aniello MS, Masi G, Lucchese V, De Candia D, Martino D. Frequency of familial aggregation in primary adult-onset cranial cervical dystonia. Neurol Sci. 2003 Oct;24(3):168-9. doi: 10.1007/s10072-003-0113-3.
PubMed 14598070
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Surround Inhibition During Phasic Compared to Tonic Voluntary Finger Movement in Focal Hand Dystonia
- ClinicalTrials.gov ID
- NCT00376753
- Acronym / sponsor ID
- 060242
- Conditions
- Focal Hand Dystonia
- Keywords
- Transcranial Magnetic Stimulation (TMS), Writer's Cramp, Electromyogram, Focal Hand Dystonia, FHD, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 11 Sep 2006
- Study completion
- 11 May 2011
- First posted
- 15 Sep 2006 (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 examine and compare brain activity in people with focal hand dystonia (FHD) and healthy volunteers to obtain further knowledge about the underlying cause of FHD. Patients with dystonia have muscle spasms that cause abnormal postures while trying to perform a movement; FHD affects the hands and fine finger movements. During fine finger movement, the brain controls muscles in a process called surround inhibition. This process may be impaired in people with hand dystonia, leading to uncontrolled overactivity in muscles and impairing motor function.
Healthy volunteers and patients with FHD over 18 years of age may be eligible for this study. Candidates are screened with a physical and neurological examination.
In a series of three experiments conducted during a single clinic visit, participants undergo transcranial magnetic stimulation (TMS) while performing a finger movement. A wire coil is placed on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the outer part of the brain. The stimulation may cause muscle, hand or arm twitching, or may affect movement or reflexes. During the stimulation, the subject is asked to contract one finger.
In addition to TMS, subjects have surface electromyography. For this test, they sit in a chair with their hands placed on a pillow on their lap. The electrical activity of three muscles in the right hand is recorded by electrodes (small metal disks) taped to the skin over the muscles.
Detailed description
OBJECTIVE:
In sensory systems, a neural mechanism called surround inhibition (SI) sharpens sensation by creating an inhibitory zone around the central core of activation. This principle was described for the visual system first, but there is evidence for similar mechanisms in the primary motor cortex (M1) involved in movement generation and control, especially in precise motor tasks. Dystonia is generally regarded as a motor execution abnormality due to a dysfunction in the cortico-striato-thalamo-cortical motor loop. Using transcranial magnetic stimulation (TMS), recent findings point to highly task-specific impairment of motor cortical inhibition in patients with focal hand dystonia (FHD).
The goal for this research proposal is to understand the underlying physiology as it relates to different inhibitory pathways on movement generation and control. To achieve this goal, different modes of voluntary contractions will be examined in healthy controls and patients with FHD with the prospect of having new options for treatment.
STUDY POPULATION:
We intend to study 100 adult patients with FHD and 100 healthy volunteers on an outpatient basis.
DESIGN:
Participants will perform a contraction of the first dorsal interosseous muscle (FDI). At rest, before EMG-onset (premotor), during phasic and tonic contraction single TMS pulses (Experiment 1) or double TMS pulses (Experiment 2) will be applied over the primary motor cortex to assess activation-induced changes in cortical excitability in the abductor pollicis brevis muscle (APB), which is not activated. Additionally the influence of visual feedback on short intracortical inhibition (SICI) will be tested in Experiment 3. In Experiment 4-8 interhemispheric (IHI), ventral and dorso-lateral premotor-motor intracortical inhibition will be assessed.
OUTCOME MEASURES:
The primary outcome measure for Experiment 1 will be the difference in MEP peak-to-peak amplitude between all motor conditions.
The primary outcome measure for Experiment 2, 5, 6, 7 and 8 will be the difference in normalized MEP peak-to-peak amplitude between all motor conditions in FHD patients and healthy volunteers.
In Experiments 1 and 2, the change in MEP peak-to-peak amplitude between different force levels (10% versus 20%) will be a second outcome parameter.
The primary outcome parameter for Experiment 3 will be change in MEP peak-to-peak between patients and healthy volunteers during tonic contraction with and without visual feedback.
In Experiment 4, Hmax/Mmax ratio will be the primary outcome parameter.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old or older
- Presence of FHD, for Experiment 5, 6, 7 and 8 the affected limb has to be the right and dominant side
- 18 years old or older
- Right handedness
- Absence of dystonia or other neurological disorder with any effect on the motor or sensory systems
Key exclusion criteria (9 listed)
- Concurrent significant medical, surgical, neurological or psychiatric condition
- Taking the following medications: antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
- Patients- Received botulinum toxin injection within 3 months of starting the protocol
- For TMS: Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye
- History of seizure disorder
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
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 9679773Berardelli A, Rothwell JC, Hallett M, Thompson PD, Manfredi M, Marsden CD. The pathophysiology of primary dystonia. Brain. 1998 Jul;121 ( Pt 7):1195-212. doi: 10.1093/brain/121.7.1195.
- Background: PubMed 9750907Bressman SB, de Leon D, Raymond D, Greene PE, Brin MF, Fahn S, Ozelius LJ, Breakefield XO, Kramer PL, Risch NJ. The role of the DYT1 gene in secondary dystonia. Adv Neurol. 1998;78:107-15. No abstract available.
- Background: PubMed 14598070Defazio G, Aniello MS, Masi G, Lucchese V, De Candia D, Martino D. Frequency of familial aggregation in primary adult-onset cranial cervical dystonia. Neurol Sci. 2003 Oct;24(3):168-9. doi: 10.1007/s10072-003-0113-3.
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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?
An observational study of Focal Hand 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 7 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00376753, which also lists 3 linked publications.
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 Jul 2017.