Cervical DystoniaNCT04057911
A Trial of Non-invasive Stimulation in Cervical Dystonia
A study testing Active NIBS in people with Cervical Dystonia, run by Western University, Canada at 1 site in Canada.
Trial summary
Cervical dystonia (CD) is a common movement disorder. Despite the optimization of botulinum toxin injection (BoNT-A) parameters including muscle selection and dosing, a significant proportion of patients report low levels of satisfaction, and a few of them develop resistance to therapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Active NIBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2019to Oct 2021
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cervical dystonia who are already on 3 monthly BoNT-A therapy but the effect of BoNT-A is wearing off in 8 weeks.
Who cannot join
- Patients who have other issues like known structural etiology, that can aggravate cervical dystonia
- Patients who are not able to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Cervical dystonia (CD) is a common movement disorder. Despite the optimization of botulinum toxin injection (BoNT-A) parameters including muscle selection and dosing, a significant proportion of patients report low levels of satisfaction, and a few of them develop resistance to therapy. The only options for such patients would be invasive therapy such as pallidotomy or pallidal deep brain stimulation. Currently, studies are going on the effectiveness of noninvasive neurostimulation in different neurological disorders. Transcranial Direct Current Stimulation (tDCS) or transcranial pulsed current stimulation (tPCS) are known to be safe non-invasive intervention with almost no side effects that can be used to provide complementary treatment. To detect the dysfunctional regions five min resting state quantitative EEG (qEEG) eyes closed will be recorded and analyzed each time before and after noninvasive stimulation. The investigators will evaluate the efficacy of acute noninvasive stimulation in those CD patients who are already on 3 monthly BoNT-A therapy but the effect of BoNT-A is wearing off in 8 weeks. Kinematics (static and dynamic movements) of neck movements will be recorded using established technology before and after stimulation.
Read the detailed description
Cervical dystonia (CD) is the most common adult onset dystonia. Abnormal sensorimotor integration and maladaptive plasticity have been proposed as possible mechanisms. Currently, there is no definite way to assess and modify this dysfunctional network. Deep brain stimulation (DBS) is one possible way, but it is invasive and being used in highly selected patients. Intramuscular injections of botulinum toxin injection (BoNT-A) are successful. However, 30% patients discontinue due to lack of efficacy, side effects like muscle atrophy and dysphagia and the effect may wear off by week 8. Importantly, injections don't change the abnormal networks, as patients need life-long treatment.
Noninvasive brain stimulation (NIBS) is an evolving therapeutic option. Repetitive transcranial magnetic stimulation (rTMS) has already been used in network modulation in CD. Although effective, cost, lack of portability and side effects remain issues of rTMS. Portable, better tolerated and cheaper options using transcranial direct current stimulation (tDCS) in Parkinson's disease, dystonia, tremor, ataxia and transcranial pulsed current stimulation (tPCS) in Parkinson's disease are exciting new options. However, with these methods of NIS, many challenges remain - dysfunctional network localization, selecting parameters to use, providing adequate stimulation to alter the network consistently, maintain the therapeutic benefit chronically and have consistent adoption by the patient and clinician community. These variables make this exciting approach high risk, yet high yield if successful.
In this study, the investigators will use a new quantitative electroencephalography (qEEG) technique to first localize global network dysfunction in CD. Kinematic analysis of the biomechanics of CD will be recorded. The efficacy of acute NIBS will be evaluated in those CD patients who are already on 3 monthly BoNT-A therapy but the effect of BoNT-A is wearing off in 8 weeks.The effect will be measured using qEEG and kinematics pre and post stimulation.
Noninvasive stimulation will be delivered through a pair of saline-soaked (0.9% NaCl) surface sponge electrodes. Stimulation will be given for 20 mins, single session. For the sham condition, the electrode placement will be same, but the electric current will be ramped down in 5 seconds after the beginning of the stimulation.
Neurophysiological EEG signals will be recorded, eyes-closed, no-task, using g.Nautilus g.tec wireless system. The g.tech system uses earclip reference sensors. The subject will be in a quiet place with less light or electromagnetic perturbations. During the resting state recordings, patients are seated in a comfortable arm chair and will be instructed to keep relaxed, with their eyes closed for 5 mins.
A paired t test will be used to compare baseline data and post tPCS data. Descriptive analysis of the neurological examination findings will be provided.
- Conditions
- Cervical Dystonia
- Being tested
- Active NIBS, Sham NIBS
- Keywords
- Cervical dystonia, Non-invasive stimulation
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active NIBSDevice
Cathodal noninvasive brain stimulation will be given for 20 mins.
Sham NIBSDevice
The electrode placement will be same, but the electric current will be ramped down 5 seconds after the beginning of the stimulation
| Study group | Role | What they receive |
|---|---|---|
| Real NIBS | Experimental | In Real NIBS arm, active Noninvasive brain stimulation (NIBS) will be given for 20 mins. Receives: Device: Active NIBS |
| Sham NIBS | Sham comparator | In Sham NIBS arm, sham Noninvasive brain stimulation (NIBS) will be given for 20 mins. Receives: Device: Sham NIBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS).
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) will be assessed before and after stimulation. This scale is used to assess the severity of cervical dystonia and the success of its treatment. A total score of 0 to 35 can be achieved; this is made up of various sub scores- maximal excursion, duration of neck deviation, effect of sensory tricks, shoulder elevation/anterior displacement, range of motion, time to maintain in neutral position.
Measured: 3 months
Changes in Network fragmentation using Quantitative Electroencephalography (qEEG)
We will do network fragmentation by 5 mins of resting quantitative Electroencephalography (EEG), pre and post stimulation. All the frequency bands will be analyzed. The change of frequency bands leading to change in network fragmentation will plotted.
Measured: 3 months
Kinematic changes in angular deviation and amplitude measures
Angular deviations will be calculated by degree of freedom angular bias from calibrated neutral position. Amplitude measures will be reported as root mean square values.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mandar Jog, Western University, Canada
- Investigators
- Mandar Jog, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057911
- Sponsor's protocol ID
- 114198
- Status last verified
- Sep 2019
- First submitted
- 9 Aug 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bradnam LV, Frasca J, Kimberley TJ. Direct current stimulation of primary motor cortex and cerebellum and botulinum toxin a injections in a person with cervical dystonia. Brain Stimul. 2014 Nov-Dec;7(6):909-11. doi: 10.1016/j.brs.2014.09.008. Epub 2014 Oct 7. No abstract available.
PubMed 25440290Angelakis E, Liouta E, Andreadis N, Leonardos A, Ktonas P, Stavrinou LC, Miranda PC, Mekonnen A, Sakas DE. Transcranial alternating current stimulation reduces symptoms in intractable idiopathic cervical dystonia: a case study. Neurosci Lett. 2013 Jan 15;533:39-43. doi: 10.1016/j.neulet.2012.11.007. Epub 2012 Nov 10.
PubMed 23149130
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Non-invasive Stimulation in Cervical Dystonia
- ClinicalTrials.gov ID
- NCT04057911
- Acronym / sponsor ID
- 114198
- Conditions
- Cervical Dystonia
- Keywords
- Cervical dystonia, Non-invasive stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 15 Aug 2019 (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.
Cervical dystonia (CD) is a common movement disorder. Despite the optimization of botulinum toxin injection (BoNT-A) parameters including muscle selection and dosing, a significant proportion of patients report low levels of satisfaction, and a few of them develop resistance to therapy. The only options for such patients would be invasive therapy such as pallidotomy or pallidal deep brain stimulation. Currently, studies are going on the effectiveness of noninvasive neurostimulation in different neurological disorders. Transcranial Direct Current Stimulation (tDCS) or transcranial pulsed current stimulation (tPCS) are known to be safe non-invasive intervention with almost no side effects that can be used to provide complementary treatment. To detect the dysfunctional regions five min resting state quantitative EEG (qEEG) eyes closed will be recorded and analyzed each time before and after noninvasive stimulation. The investigators will evaluate the efficacy of acute noninvasive stimulation in those CD patients who are already on 3 monthly BoNT-A therapy but the effect of BoNT-A is wearing off in 8 weeks. Kinematics (static and dynamic movements) of neck movements will be recorded using established technology before and after stimulation.
Detailed description
Cervical dystonia (CD) is the most common adult onset dystonia. Abnormal sensorimotor integration and maladaptive plasticity have been proposed as possible mechanisms. Currently, there is no definite way to assess and modify this dysfunctional network. Deep brain stimulation (DBS) is one possible way, but it is invasive and being used in highly selected patients. Intramuscular injections of botulinum toxin injection (BoNT-A) are successful. However, 30% patients discontinue due to lack of efficacy, side effects like muscle atrophy and dysphagia and the effect may wear off by week 8. Importantly, injections don't change the abnormal networks, as patients need life-long treatment.
Noninvasive brain stimulation (NIBS) is an evolving therapeutic option. Repetitive transcranial magnetic stimulation (rTMS) has already been used in network modulation in CD. Although effective, cost, lack of portability and side effects remain issues of rTMS. Portable, better tolerated and cheaper options using transcranial direct current stimulation (tDCS) in Parkinson's disease, dystonia, tremor, ataxia and transcranial pulsed current stimulation (tPCS) in Parkinson's disease are exciting new options. However, with these methods of NIS, many challenges remain - dysfunctional network localization, selecting parameters to use, providing adequate stimulation to alter the network consistently, maintain the therapeutic benefit chronically and have consistent adoption by the patient and clinician community. These variables make this exciting approach high risk, yet high yield if successful.
In this study, the investigators will use a new quantitative electroencephalography (qEEG) technique to first localize global network dysfunction in CD. Kinematic analysis of the biomechanics of CD will be recorded. The efficacy of acute NIBS will be evaluated in those CD patients who are already on 3 monthly BoNT-A therapy but the effect of BoNT-A is wearing off in 8 weeks.The effect will be measured using qEEG and kinematics pre and post stimulation.
Noninvasive stimulation will be delivered through a pair of saline-soaked (0.9% NaCl) surface sponge electrodes. Stimulation will be given for 20 mins, single session. For the sham condition, the electrode placement will be same, but the electric current will be ramped down in 5 seconds after the beginning of the stimulation.
Neurophysiological EEG signals will be recorded, eyes-closed, no-task, using g.Nautilus g.tec wireless system. The g.tech system uses earclip reference sensors. The subject will be in a quiet place with less light or electromagnetic perturbations. During the resting state recordings, patients are seated in a comfortable arm chair and will be instructed to keep relaxed, with their eyes closed for 5 mins.
A paired t test will be used to compare baseline data and post tPCS data. Descriptive analysis of the neurological examination findings will be provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real NIBS | Experimental | Device: Active NIBSIn Real NIBS arm, active Noninvasive brain stimulation (NIBS) will be given for 20 mins. |
| Sham NIBS | Sham comparator | Device: Sham NIBSIn Sham NIBS arm, sham Noninvasive brain stimulation (NIBS) will be given for 20 mins. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with cervical dystonia who are already on 3 monthly BoNT-A therapy but the effect of BoNT-A is wearing off in 8 weeks.
Key exclusion criteria (2 listed)
- Patients who have other issues like known structural etiology, that can aggravate cervical dystonia
- Patients who are not able to provide informed consent
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 |
|---|---|---|
| Active NIBSCathodal noninvasive brain stimulation will be given for 20 mins. | Device | Real NIBS |
| Sham NIBSThe electrode placement will be same, but the electric current will be ramped down 5 seconds after the beginning of the stimulation | Device | Sham NIBS |
Primary outcome
Changes in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS).
Time frame: 3 months
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) will be assessed before and after stimulation. This scale is used to assess the severity of cervical dystonia and the success of its treatment. A total score of 0 to 35 can be achieved; this is made up of various sub scores- maximal excursion, duration of neck deviation, effect of sensory tricks, shoulder elevation/anterior displacement, range of motion, time to maintain in neutral position.
Changes in Network fragmentation using Quantitative Electroencephalography (qEEG)
Time frame: 3 months
We will do network fragmentation by 5 mins of resting quantitative Electroencephalography (EEG), pre and post stimulation. All the frequency bands will be analyzed. The change of frequency bands leading to change in network fragmentation will plotted.
Kinematic changes in angular deviation and amplitude measures
Time frame: 3 months
Angular deviations will be calculated by degree of freedom angular bias from calibrated neutral position. Amplitude measures will be reported as root mean square values.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 25440290Bradnam LV, Frasca J, Kimberley TJ. Direct current stimulation of primary motor cortex and cerebellum and botulinum toxin a injections in a person with cervical dystonia. Brain Stimul. 2014 Nov-Dec;7(6):909-11. doi: 10.1016/j.brs.2014.09.008. Epub 2014 Oct 7. No abstract available.
- Background: PubMed 23149130Angelakis E, Liouta E, Andreadis N, Leonardos A, Ktonas P, Stavrinou LC, Miranda PC, Mekonnen A, Sakas DE. Transcranial alternating current stimulation reduces symptoms in intractable idiopathic cervical dystonia: a case study. Neurosci Lett. 2013 Jan 15;533:39-43. doi: 10.1016/j.neulet.2012.11.007. Epub 2012 Nov 10.
- 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.
Mandar Jog, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active NIBS in people with Cervical Dystonia, run by Western University, Canada at 1 site in Canada.
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 2 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: status not confirmed, as of the sponsor's last update on 26 Sep 2019. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mandar Jog, MD (5196858500 ext. 33814, Mandar.Jog@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT04057911, which also lists 2 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 Sep 2019.