A Trial of Non-invasive Stimulation in Cervical Dystonia
Keywords
Abstract
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.
Dates
| Last Verified: | 08/31/2019 |
| First Submitted: | 08/08/2019 |
| Estimated Enrollment Submitted: | 08/13/2019 |
| First Posted: | 08/14/2019 |
| Last Update Submitted: | 09/23/2019 |
| Last Update Posted: | 09/25/2019 |
| Actual Study Start Date: | 08/31/2019 |
| Estimated Primary Completion Date: | 08/31/2021 |
| Estimated Study Completion Date: | 09/30/2021 |
Condition or disease
Intervention/treatment
Device: Real NIBS
Device: Sham NIBS
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Real NIBS In Real NIBS arm, active Noninvasive brain stimulation (NIBS) will be given for 20 mins. | Device: Real 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 |
Eligibility Criteria
| Ages Eligible for Study | 20 Years To 20 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - 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. Exclusion Criteria: - Patients who have other issues like known structural etiology, that can aggravate cervical dystonia - Patients who are not able to provide informed consent |
Outcome
Primary Outcome Measures
1. Changes in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). [3 months]
2. Changes in Network fragmentation using Quantitative Electroencephalography (qEEG) [3 months]
3. Kinematic changes in angular deviation and amplitude measures [3 months]
