Writer's CrampVTS in WCNCT07894198
VTS Sensorimotor Neuromodulation in WC
A study testing Vibro-tactile stimulation in people with Writer's Cramp and Dystonias, run by Ottawa Hospital Research Institute.
Trial summary
Writer's cramps (WC) is a focal task-specific upper limb dystonia that significantly impairs handwriting and other manual skills, affecting functionality. WC is one of the most common task-specific dystonias, affecting 3.8-80 per million individuals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Writer's Cramp, Dystonias
- What is being tested?
- Vibro-tactile stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of WC confirmed by a movement disorders specialist.
Who cannot join
- The presence of other neurological or musculoskeletal disorders affecting dominant hand function
- The use of oral pharmacologic treatments for dystonia in the last 3 months
- Treatment with botulinum toxin injections for WC within the past 10 weeks.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Vibro-tactile Stimulation Sensorimotor Neuromodulation in Writer's Cramps: a Pilot Study
Writer's cramps (WC) is a focal task-specific upper limb dystonia that significantly impairs handwriting and other manual skills, affecting functionality. WC is one of the most common task-specific dystonias, affecting 3.8-80 per million individuals. The first-line management option is botulinum toxin injections in the muscles affected by the involuntary movements, causing a transient neuromuscular blocking effect and reducing muscle abnormal contraction. However, the effect lasts for around 3 months or less, is invasive, may cause unintended hand weakness, and the benefits are variable in terms of the severity of dystonic contraction and functional gain.
Focal limb dystonia pathophysiology, including writer's cramps, has been linked to propriospinal signalling defects in the sensorimotor cortex modulation5, prompting an investigation into neuromodulation of this region as a modality for dystonia management.
Read more
Other forms of dystonia have shown a reduction of the involuntary movements with vibrotactile stimulation (VTS), including cervical and laryngeal dystonia8. These results have supported the hypothesis that VTS alters the abnormal output of mechanical receptors from proprioceptive and tactile pathways to the sensorimotor cortex.Changes in neurophysiological markers of dystonia in the sensorimotor cortex also corroborated the modulatory effect.
Furthermore, more invasive methods of neuromodulation, such as Globus Pallidus internus Deep Brain Stimulation, are known to be an effective treatment option for medically refractory dystonia, with evidence of promoting a similar result on the sensorimotor pathway via cortico-basal ganglia network direct stimulation. Finally, one of the most common ways of modulation is a core feature in dystonia, which is called an alleviating manoeuvre (AM) or geste antagoniste. This comprises a sensory or motor stimulation located in the anatomical area of the dystonia, which will transiently alleviate the involuntary movement. In that case, Functional MRI studies also suggest a sensorimotor network modulation in AM. Thus, there is considerable preliminary evidence to suggest the role of invasive and non-invasive neuromodulation in the treatment of dystonia.
Given the variable and often suboptimal response to standard treatments for task-specific dystonia, such as WC, and the associated functional impairment, this study explores the role of vibrotactile stimulation (VTS) as a non-invasive neuromodulation tool for WC. VTS targets muscles involved in dystonic contractions, intending to create a non-invasive neuromodulation via propriospinal pathways to the sensorimotor cortex and improve motor control in individuals with WC. The effect described in previous studies lasts around 20-30 minutes, which should allow functionality for handwriting during that period of time. In the future, with the refinement of the technique's effectiveness, it could be escalated for a wearable treatment option.
Based on the clinical and pathophysiological characteristics of task-specific dystonia it is reasonable to use a peripheral sensory modulation technique to try and reduced the abnormal motor cortical output this way reducing the dystonic movement. That has been proved successful in other types of dystonia. Thus, a pilot study for proof-of-concept concept and feasibility is a good first step towards that direction.
- Conditions
- Writer's Cramp, Dystonias
- Being tested
- Vibro-tactile stimulation
- Keywords
- writer's cramp, vibro-tactile stimulation, task-specific dystonia
- Medical subject headings
- Dystonic Disorders, Dystonia, Focal, Task-Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibro-tactile stimulationDevice
Participants will undergo research visits for a vibro-tactile stimulation session in the forearm muscles of the dominant hand. These encounters will include a baseline assessment (pre-stimulation), an assessment during a continuous stimulation period, a third assessment 20 minutes after, and a fourth assessment 60 minutes after to assess retention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will undergo research visits for a vibro-tactile stimulation session in the forearm muscles of the dominant hand. These encounters will include a baseline assessment (pre-stimulation), an assessment during a continuous stimulation period, a third assessment 20 minutes after, and a fourth assessment 60 minutes after to assess retention. The assessments will have a specific structure detailed in the next topic. Receives: Device: Vibro-tactile stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Writer's Cramp Rating Scale
The Writer's Cramp Rating Scale is validated and widely adopted in botulinum toxin trials for WC treatment. The Writer's Cramp Rating Scale quantify dystonia severity by measuring involuntary movements and handwriting speed. It provides a structured, objective measure of motor control specific to WC. The total score ranges from 0 to 30, with 0 indicating no writer's cramp symptoms and 30 indicating maximum severity. Higher scores indicate worse outcomes, while a reduction in the score indicates clinical improvement.
Measured: 2 weeks
Secondary outcomes (1)
Subjective Perception of Improvement Questionnaire
Captures participant-perceived functional benefit that may not be fully reflected by clinician-rated scales. The questionnaire consists of six items, each rated on an 11-point numerical scale ranging from 0 to 10. The total score ranges from 0 to 60, with higher scores indicating greater perceived improvement (better outcomes)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Writer's CrampStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894198
- Sponsor's protocol ID
- 20260311-01H
- Acronym
- VTS in WC
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wissel J, Kabus C, Wenzel R, Klepsch S, Schwarz U, Nebe A, Schelosky L, Scholz U, Poewe W. Botulinum toxin in writer's cramp: objective response evaluation in 31 patients. J Neurol Neurosurg Psychiatry. 1996 Aug;61(2):172-5. doi: 10.1136/jnnp.61.2.172.
PubMed 8708685Sarasso E, Agosta F, Piramide N, Bianchi F, Butera C, Gatti R, Amadio S, Del Carro U, Filippi M. Sensory trick phenomenon in cervical dystonia: a functional MRI study. J Neurol. 2020 Apr;267(4):1103-1115. doi: 10.1007/s00415-019-09683-5. Epub 2020 Jan 2.
PubMed 31897600Filip P, Jech R, Fecikova A, Havrankova P, Ruzicka F, Mueller K, Urgosik D. Restoration of functional network state towards more physiological condition as the correlate of clinical effects of pallidal deep brain stimulation in dystonia. Brain Stimul. 2022 Sep-Oct;15(5):1269-1278. doi: 10.1016/j.brs.2022.08.025. Epub 2022 Sep 9.
PubMed 36096443Cordo P, Gurfinkel VS, Bevan L, Kerr GK. Proprioceptive consequences of tendon vibration during movement. J Neurophysiol. 1995 Oct;74(4):1675-88. doi: 10.1152/jn.1995.74.4.1675.
PubMed 8989404BIANCONI R, van der MEULEN J. The response to vibration of the end organs of mammalian muscle spindles. J Neurophysiol. 1963 Jan;26:177-90. doi: 10.1152/jn.1963.26.1.177. No abstract available.
PubMed 13968075Khosravani S, Mahnan A, Yeh IL, Aman JE, Watson PJ, Zhang Y, Goding G, Konczak J. Laryngeal vibration as a non-invasive neuromodulation therapy for spasmodic dysphonia. Sci Rep. 2019 Nov 29;9(1):17955. doi: 10.1038/s41598-019-54396-4.
PubMed 31784618Avanzino L, Xu J, Martino D, Conte A, Standal S, Salehi P, Terranova S, Bonassi G, Alizadeh P, Adeoti JA, Belvisi D, Costanzo M, Oh J, Konczak J. Vibro-tactile stimulation of the neck induces head righting in people with cervical dystonia. Parkinsonism Relat Disord. 2025 Mar;132:107263. doi: 10.1016/j.parkreldis.2025.107263. Epub 2025 Jan 16.
PubMed 39848136Zhu Y, Mahnan A, Konczak J. Vibro-Tactile Stimulation as a Non-Invasive Neuromodulation Therapy for Cervical Dystonia: A Case Study. Annu Int Conf IEEE Eng Med Biol Soc. 2021 Nov;2021:6314-6317. doi: 10.1109/EMBC46164.2021.9629717.
PubMed 34892557Dresel C, Li Y, Wilzeck V, Castrop F, Zimmer C, Haslinger B. Multiple changes of functional connectivity between sensorimotor areas in focal hand dystonia. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1245-52. doi: 10.1136/jnnp-2013-307127. Epub 2014 Apr 4.
PubMed 24706945Kruisdijk JJ, Koelman JH, Ongerboer de Visser BW, de Haan RJ, Speelman JD. Botulinum toxin for writer's cramp: a randomised, placebo-controlled trial and 1-year follow-up. J Neurol Neurosurg Psychiatry. 2007 Mar;78(3):264-70. doi: 10.1136/jnnp.2005.083170. Epub 2006 Dec 21.
PubMed 17185301Defazio G, Berardelli A, Hallett M. Do primary adult-onset focal dystonias share aetiological factors? Brain. 2007 May;130(Pt 5):1183-93. doi: 10.1093/brain/awl355. Epub 2007 Jan 22.
PubMed 17242025Amini D. Occupational therapy interventions for work-related injuries and conditions of the forearm, wrist, and hand: a systematic review. Am J Occup Ther. 2011 Jan-Feb;65(1):29-36. doi: 10.5014/ajot.2011.09186.
PubMed 21309369
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibro-tactile Stimulation Sensorimotor Neuromodulation in Writer's Cramps: a Pilot Study
- ClinicalTrials.gov ID
- NCT07894198
- Acronym / sponsor ID
- VTS in WC / 20260311-01H
- Conditions
- Writer's Cramp, Dystonias
- Keywords
- writer's cramp, vibro-tactile stimulation, task-specific dystonia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 26 Oct 2026 (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.
Writer's cramps (WC) is a focal task-specific upper limb dystonia that significantly impairs handwriting and other manual skills, affecting functionality. WC is one of the most common task-specific dystonias, affecting 3.8-80 per million individuals. The first-line management option is botulinum toxin injections in the muscles affected by the involuntary movements, causing a transient neuromuscular blocking effect and reducing muscle abnormal contraction. However, the effect lasts for around 3 months or less, is invasive, may cause unintended hand weakness, and the benefits are variable in terms of the severity of dystonic contraction and functional gain.
Focal limb dystonia pathophysiology, including writer's cramps, has been linked to propriospinal signalling defects in the sensorimotor cortex modulation5, prompting an investigation into neuromodulation of this region as a modality for dystonia management.
Other forms of dystonia have shown a reduction of the involuntary movements with vibrotactile stimulation (VTS), including cervical and laryngeal dystonia8. These results have supported the hypothesis that VTS alters the abnormal output of mechanical receptors from proprioceptive and tactile pathways to the sensorimotor cortex.Changes in neurophysiological markers of dystonia in the sensorimotor cortex also corroborated the modulatory effect.
Furthermore, more invasive methods of neuromodulation, such as Globus Pallidus internus Deep Brain Stimulation, are known to be an effective treatment option for medically refractory dystonia, with evidence of promoting a similar result on the sensorimotor pathway via cortico-basal ganglia network direct stimulation. Finally, one of the most common ways of modulation is a core feature in dystonia, which is called an alleviating manoeuvre (AM) or geste antagoniste. This comprises a sensory or motor stimulation located in the anatomical area of the dystonia, which will transiently alleviate the involuntary movement. In that case, Functional MRI studies also suggest a sensorimotor network modulation in AM. Thus, there is considerable preliminary evidence to suggest the role of invasive and non-invasive neuromodulation in the treatment of dystonia.
Given the variable and often suboptimal response to standard treatments for task-specific dystonia, such as WC, and the associated functional impairment, this study explores the role of vibrotactile stimulation (VTS) as a non-invasive neuromodulation tool for WC. VTS targets muscles involved in dystonic contractions, intending to create a non-invasive neuromodulation via propriospinal pathways to the sensorimotor cortex and improve motor control in individuals with WC. The effect described in previous studies lasts around 20-30 minutes, which should allow functionality for handwriting during that period of time. In the future, with the refinement of the technique's effectiveness, it could be escalated for a wearable treatment option.
Based on the clinical and pathophysiological characteristics of task-specific dystonia it is reasonable to use a peripheral sensory modulation technique to try and reduced the abnormal motor cortical output this way reducing the dystonic movement. That has been proved successful in other types of dystonia. Thus, a pilot study for proof-of-concept concept and feasibility is a good first step towards that direction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Vibro-tactile stimulationParticipants will undergo research visits for a vibro-tactile stimulation session in the forearm muscles of the dominant hand. These encounters will include a baseline assessment (pre-stimulation), an assessment during a continuous stimulation period, a third assessment 20 minutes after, and a fourth assessment 60 minutes after to assess retention. The assessments will have a specific structure detailed in the next topic. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of WC confirmed by a movement disorders specialist.
Key exclusion criteria (3 listed)
- The presence of other neurological or musculoskeletal disorders affecting dominant hand function
- The use of oral pharmacologic treatments for dystonia in the last 3 months
- Treatment with botulinum toxin injections for WC within the past 10 weeks.
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 |
|---|---|---|
| Vibro-tactile stimulationParticipants will undergo research visits for a vibro-tactile stimulation session in the forearm muscles of the dominant hand. These encounters will include a baseline assessment (pre-stimulation), an assessment during a continuous stimulation period, a third assessment 20 minutes after, and a fourth assessment 60 minutes after to assess retention. | Device | Intervention |
Primary outcome
Writer's Cramp Rating Scale
Time frame: 2 weeks
The Writer's Cramp Rating Scale is validated and widely adopted in botulinum toxin trials for WC treatment. The Writer's Cramp Rating Scale quantify dystonia severity by measuring involuntary movements and handwriting speed. It provides a structured, objective measure of motor control specific to WC. The total score ranges from 0 to 30, with 0 indicating no writer's cramp symptoms and 30 indicating maximum severity. Higher scores indicate worse outcomes, while a reduction in the score indicates clinical improvement.
1 secondary outcome
Subjective Perception of Improvement Questionnaire
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 8708685Wissel J, Kabus C, Wenzel R, Klepsch S, Schwarz U, Nebe A, Schelosky L, Scholz U, Poewe W. Botulinum toxin in writer's cramp: objective response evaluation in 31 patients. J Neurol Neurosurg Psychiatry. 1996 Aug;61(2):172-5. doi: 10.1136/jnnp.61.2.172.
- Background: PubMed 31897600Sarasso E, Agosta F, Piramide N, Bianchi F, Butera C, Gatti R, Amadio S, Del Carro U, Filippi M. Sensory trick phenomenon in cervical dystonia: a functional MRI study. J Neurol. 2020 Apr;267(4):1103-1115. doi: 10.1007/s00415-019-09683-5. Epub 2020 Jan 2.
- Background: PubMed 36096443Filip P, Jech R, Fecikova A, Havrankova P, Ruzicka F, Mueller K, Urgosik D. Restoration of functional network state towards more physiological condition as the correlate of clinical effects of pallidal deep brain stimulation in dystonia. Brain Stimul. 2022 Sep-Oct;15(5):1269-1278. doi: 10.1016/j.brs.2022.08.025. Epub 2022 Sep 9.
- Background: PubMed 8989404Cordo P, Gurfinkel VS, Bevan L, Kerr GK. Proprioceptive consequences of tendon vibration during movement. J Neurophysiol. 1995 Oct;74(4):1675-88. doi: 10.1152/jn.1995.74.4.1675.
- Background: PubMed 13968075BIANCONI R, van der MEULEN J. The response to vibration of the end organs of mammalian muscle spindles. J Neurophysiol. 1963 Jan;26:177-90. doi: 10.1152/jn.1963.26.1.177. No abstract available.
- Background: PubMed 31784618Khosravani S, Mahnan A, Yeh IL, Aman JE, Watson PJ, Zhang Y, Goding G, Konczak J. Laryngeal vibration as a non-invasive neuromodulation therapy for spasmodic dysphonia. Sci Rep. 2019 Nov 29;9(1):17955. doi: 10.1038/s41598-019-54396-4.
- Background: PubMed 39848136Avanzino L, Xu J, Martino D, Conte A, Standal S, Salehi P, Terranova S, Bonassi G, Alizadeh P, Adeoti JA, Belvisi D, Costanzo M, Oh J, Konczak J. Vibro-tactile stimulation of the neck induces head righting in people with cervical dystonia. Parkinsonism Relat Disord. 2025 Mar;132:107263. doi: 10.1016/j.parkreldis.2025.107263. Epub 2025 Jan 16.
- Background: PubMed 34892557Zhu Y, Mahnan A, Konczak J. Vibro-Tactile Stimulation as a Non-Invasive Neuromodulation Therapy for Cervical Dystonia: A Case Study. Annu Int Conf IEEE Eng Med Biol Soc. 2021 Nov;2021:6314-6317. doi: 10.1109/EMBC46164.2021.9629717.
- Background: PubMed 24706945Dresel C, Li Y, Wilzeck V, Castrop F, Zimmer C, Haslinger B. Multiple changes of functional connectivity between sensorimotor areas in focal hand dystonia. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1245-52. doi: 10.1136/jnnp-2013-307127. Epub 2014 Apr 4.
- Background: PubMed 17185301Kruisdijk JJ, Koelman JH, Ongerboer de Visser BW, de Haan RJ, Speelman JD. Botulinum toxin for writer's cramp: a randomised, placebo-controlled trial and 1-year follow-up. J Neurol Neurosurg Psychiatry. 2007 Mar;78(3):264-70. doi: 10.1136/jnnp.2005.083170. Epub 2006 Dec 21.
- Background: PubMed 17242025Defazio G, Berardelli A, Hallett M. Do primary adult-onset focal dystonias share aetiological factors? Brain. 2007 May;130(Pt 5):1183-93. doi: 10.1093/brain/awl355. Epub 2007 Jan 22.
- Background: PubMed 21309369Amini D. Occupational therapy interventions for work-related injuries and conditions of the forearm, wrist, and hand: a systematic review. Am J Occup Ther. 2011 Jan-Feb;65(1):29-36. doi: 10.5014/ajot.2011.09186.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Vibro-tactile stimulation in people with Writer's Cramp and Dystonias, run by Ottawa Hospital Research Institute.
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 3 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Amorelli (6137985555 ext. 18162, gamorelli@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Writer's Cramp Rating Scale (time frame: 2 weeks). 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 NCT07894198, which also lists 12 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 26 Oct 2026.