A Trial of Non-invasive Stimulation in Cervical Dystonia
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|ClinicalTrials.gov Identifier: NCT04057911|
Recruitment Status : Not yet recruiting
First Posted : August 15, 2019
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cervical Dystonia||Device: Active NIBS Device: Sham NIBS||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Trial of Non-invasive Stimulation in Cervical Dystonia|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||October 2021|
Experimental: Real NIBS
In Real NIBS arm, active Noninvasive brain stimulation (NIBS) will be given for 20 mins.
Device: Active NIBS
Cathodal noninvasive brain stimulation will be given for 20 mins.
Sham Comparator: Sham NIBS
In Sham NIBS arm, sham Noninvasive brain stimulation (NIBS) will be given for 20 mins.
Device: Sham NIBS
The electrode placement will be same, but the electric current will be ramped down 5 seconds after the beginning of the stimulation
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057911
|Contact: Mandar Jog, MD||5196858500 ext 33814||Mandar.Jog@lhsc.on.ca|
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 5A5|
|Principal Investigator:||Mandar Jog, MD||London Health Sciences Centre|