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Trial record 2 of 5 for:    NIBS | Canada

A Trial of Non-invasive Stimulation in Cervical Dystonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04057911
Recruitment Status : Not yet recruiting
First Posted : August 15, 2019
Last Update Posted : September 26, 2019
Information provided by (Responsible Party):
Mandar Jog, Western University, Canada

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cervical Dystonia Device: Active NIBS Device: Sham NIBS Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

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

Primary Outcome Measures :
  1. 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.

  2. 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. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT04057911

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Contact: Mandar Jog, MD 5196858500 ext 33814

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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Western University, Canada
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Principal Investigator: Mandar Jog, MD London Health Sciences Centre
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Responsible Party: Mandar Jog, Professor, Western University, Canada Identifier: NCT04057911    
Other Study ID Numbers: 114198
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mandar Jog, Western University, Canada:
Cervical dystonia
Non-invasive stimulation
Additional relevant MeSH terms:
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Dystonic Disorders
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases