A Trial of Non-invasive Stimulation in Cervical Dystonia

September 24, 2019 updated by: Mandar Jog, Western University, Canada
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

August 9, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 15, 2019

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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