A Trial of Non-invasive Stimulation in Cervical Dystonia

NCT04057911 | Unknown

• 1 other identifier: 114198
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Dystonia

Keywords

Cervical dystonia; Non-invasive stimulation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  3 months

Study Arms (2)

Real NIBS

EXPERIMENTAL

In Real NIBS arm, active Noninvasive brain stimulation (NIBS) will be given for 20 mins.

Device: Active NIBS

Sham NIBS

SHAM COMPARATOR

In Sham NIBS arm, sham Noninvasive brain stimulation (NIBS) will be given for 20 mins.

Device: Sham NIBS

Interventions

Active NIBS DEVICE

Cathodal noninvasive brain stimulation will be given for 20 mins.

Real NIBS

Sham NIBS DEVICE

The electrode placement will be same, but the electric current will be ramped down 5 seconds after the beginning of the stimulation

Sham NIBS

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who have other issues like known structural etiology, that can aggravate cervical dystonia
• Patients who are not able to provide informed consent

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (2)

• 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.

  PMID: 25440290 BACKGROUND

• Angelakis 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.

  PMID: 23149130 BACKGROUND

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mandar Jog, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mandar Jog, MD

CONTACT

5196858500; Mandar.Jog@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 15, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)