Dystonia, Focal, Task-specificPhase 1NCT01884064
Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia
A Phase 1 study testing rTMS in people with Dystonia, Focal, Task-specific, run by University of Minnesota at 1 site in United States.
Trial summary
This study investigated the short term effects of repeated administrations of repetitive-transcranial magnetic stimulation (rTMS) on clinical changes and investigate neurophysiologic responses to rTMS of the activated motor system in patients with FHD. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Dystonia, Focal, Task-specific
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jul 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Task specific Focal Hand Dystonia
Who cannot join
- any neurologic condition other than FHD
- medication for dystonia
- botulinum toxin within the past three months
- seizure history
- pregnancy
- implanted medical devices
Trial locations and contacts
1 site in 1 country.
United States1 site
Program in Physical Therapy, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Multiple Sessions of Low-frequency Repetitive Transcranial Magnetic Stimulation in Focal Hand Dystonia: Clinical and Physiological Effects
This study investigated the short term effects of repeated administrations of repetitive-transcranial magnetic stimulation (rTMS) on clinical changes and investigate neurophysiologic responses to rTMS of the activated motor system in patients with FHD.
Read the detailed description
Purpose: The ability of low-frequency repetitive transcranial magnetic stimulation (rTMS) to enhance intracortical inhibition has motivated its use as a potential therapeutic intervention in focal hand dystonia (FHD). In this preliminary investigation, we assessed the physiologic and behavioral effects of multiple sessions of rTMS in FHD. Methods: 12 patients with FHD underwent five daily-sessions of 1 Hz rTMS to contralateral dorsal premotor cortex (dPMC). Patients held a pencil and made movements that did not elicit dystonic symptoms during rTMS. We hypothesized that an active but non-dystonic motor state would increase beneficial effects of rTMS. Five additional patients received sham-rTMS protocol. The area under curve (AUC) of the motor evoked potentials and the cortical silent period (CSP) were measured to assess changes in corticospinal excitability and intracortical inhibition, respectively. Behavioral measures included pen force and velocity during handwriting and subjective report.
- Conditions
- Dystonia, Focal, Task-specific
- Being tested
- rTMS, Sham rTMS
- Keywords
- focal hand dystonia, rehabilitation, rTMS, writer's cramp, clinical
- Medical subject headings
- Dystonia, Focal, Task-Specific, Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Also called Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK
rTMS
Sham rTMSDevice
Also called Placebo Magstim Rapid 2, Magstim Co, Whitland Dyfed, UK
Sham rTMS
| Study group | Role | What they receive |
|---|---|---|
| inhibitory rTMS | Experimental | Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex. Patients held a pencil and made movements that did not elicit dystonic symptoms during rTMS. Intervention was delivered every day for 5 days. Receives: Device: rTMS |
| Sham rTMS | Placebo comparator | Sham Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex. Patients held a pencil and made movements that did not elicit dystonic symptoms during rTMS. Intervention was delivered every day for 5 days. Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical Silent Period
Subjects performed an isometric abduction contraction of the index finger against a strain gauge coupled to a load cell. A single TMS pulse was applied 2-3 s after contraction initiation and subjects were instructed to relax 2-3 s after stimulation. The duration of the CSP was measured on a trial-by-trial basis and was delineated by the first superimposed TMS-evoked EMG spike (onset) and the return of activity to 50% of prestimulus EMG signal (offset). The mean CSP duration was calculated for each block of measurements. The duration of CSP is thought to be related to intracortical GABAergic synapse-mediated inhibition in the stimulated cortical region. Measures of CSP have been shown to be reliable in repeated measures studies to determine an effect of intervention within a group of subjects (Orth and Rothwell 2004; Borich et al., 2009). Values are calculated as the value recorded at the latest time minus the earliest time point.
Measured: Baseline and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJul 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dystonia, Focal, Task-specificStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Dystonia Medical Research Foundation, National Institutes of Health (NIH), National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Teresa J Kimberley, PhD, PT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884064
- Sponsor's protocol ID
- 0608M91226
- Other IDs
- M01RR000400
- Status last verified
- May 2016
- First submitted
- 20 Jun 2012
- Last updated
- 17 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kimberley TJ, Borich MR, Arora S, Siebner HR. Multiple sessions of low-frequency repetitive transcranial magnetic stimulation in focal hand dystonia: clinical and physiological effects. Restor Neurol Neurosci. 2013;31(5):533-42. doi: 10.3233/RNN-120259.
PubMed 23340117
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Sessions of Low-frequency Repetitive Transcranial Magnetic Stimulation in Focal Hand Dystonia: Clinical and Physiological Effects
- ClinicalTrials.gov ID
- NCT01884064
- Acronym / sponsor ID
- 0608M91226
- Conditions
- Dystonia, Focal, Task-specific
- Keywords
- focal hand dystonia, rehabilitation, rTMS, writer's cramp, clinical
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Dystonia Medical Research Foundation, National Institutes of Health (NIH), National Center for Research Resources (NCRR)
- Study start
- Jul 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Posted 2 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated the short term effects of repeated administrations of repetitive-transcranial magnetic stimulation (rTMS) on clinical changes and investigate neurophysiologic responses to rTMS of the activated motor system in patients with FHD.
Detailed description
Purpose: The ability of low-frequency repetitive transcranial magnetic stimulation (rTMS) to enhance intracortical inhibition has motivated its use as a potential therapeutic intervention in focal hand dystonia (FHD). In this preliminary investigation, we assessed the physiologic and behavioral effects of multiple sessions of rTMS in FHD. Methods: 12 patients with FHD underwent five daily-sessions of 1 Hz rTMS to contralateral dorsal premotor cortex (dPMC). Patients held a pencil and made movements that did not elicit dystonic symptoms during rTMS. We hypothesized that an active but non-dystonic motor state would increase beneficial effects of rTMS. Five additional patients received sham-rTMS protocol. The area under curve (AUC) of the motor evoked potentials and the cortical silent period (CSP) were measured to assess changes in corticospinal excitability and intracortical inhibition, respectively. Behavioral measures included pen force and velocity during handwriting and subjective report.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inhibitory rTMS | Experimental | Device: rTMSRepetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex. Patients held a pencil and made movements that did not elicit dystonic symptoms during rTMS. Intervention was delivered every day for 5 days. |
| Sham rTMS | Placebo comparator | Device: Sham rTMSSham Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex. Patients held a pencil and made movements that did not elicit dystonic symptoms during rTMS. Intervention was delivered every day for 5 days. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Task specific Focal Hand Dystonia
Key exclusion criteria (6 listed)
- any neurologic condition other than FHD
- medication for dystonia
- botulinum toxin within the past three months
- seizure history
- pregnancy
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 |
|---|---|---|
| rTMSAlso: Magstim Rapid 2, Magstim Co, Whitland Dyfed, UKrTMS | Device | inhibitory rTMS |
| Sham rTMSAlso: Placebo Magstim Rapid 2, Magstim Co, Whitland Dyfed, UKSham rTMS | Device | Sham rTMS |
Primary outcome
Cortical Silent Period
Time frame: Baseline and Day 5
Subjects performed an isometric abduction contraction of the index finger against a strain gauge coupled to a load cell. A single TMS pulse was applied 2-3 s after contraction initiation and subjects were instructed to relax 2-3 s after stimulation. The duration of the CSP was measured on a trial-by-trial basis and was delineated by the first superimposed TMS-evoked EMG spike (onset) and the return of activity to 50% of prestimulus EMG signal (offset). The mean CSP duration was calculated for each block of measurements. The duration of CSP is thought to be related to intracortical GABAergic synapse-mediated inhibition in the stimulated cortical region. Measures of CSP have been shown to be reliable in repeated measures studies to determine an effect of intervention within a group of subjects (Orth and Rothwell 2004; Borich et al., 2009). Values are calculated as the value recorded at the latest time minus the earliest time point.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23340117Kimberley TJ, Borich MR, Arora S, Siebner HR. Multiple sessions of low-frequency repetitive transcranial magnetic stimulation in focal hand dystonia: clinical and physiological effects. Restor Neurol Neurosci. 2013;31(5):533-42. doi: 10.3233/RNN-120259.
- Individual participant dataSharing planned: No
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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.
Teresa J Kimberley, PhD, PT principal investigator
University of Minnesota
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 rTMS in people with Dystonia, Focal, Task-specific, run by University of Minnesota 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 1 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 17 Jun 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. 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.
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?
Yes. Results are posted in the registry (first posted 2 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cortical Silent Period (time frame: Baseline and Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01884064, which also lists 1 linked publication.
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 17 Jun 2016.