Recruiting

LIFUS

Sponsor:

Robert Chen

Code:

NCT07690514

Conditions

Cervical Dystonia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LIFUS - GPi Active

LIFUS - DN Active

LIFUS - Sham

Study Details

Brief summary:

This study is a single-blinded, randomized control study that aims to recruit 48 participants. Participants will be "randomized" into one of the study arms of the study: active stimulation to GPi, active stimulation to DN, or sham stimulation. The purpose of the study is to look into the effects of LIFUS in patients with cervical dystonia. The participation will include seven study visits, at least 24 hours apart. All study visits will take place at TWH. The first visit is a screening visit. Visits 2-6 will be on consecutive days. Visit 7 will be a week from Visit 6 or from your last day of LIFUS, whichever comes first.

Conditions

Cervical Dystonia

Study ID

NCT07690514

Start date

Nov 18, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 - 90 years of age
  • Confirmed diagnosis cervical dystonia
  • 3 months since last botulinum toxin injection
  • Stable medications in the past month

Exclusion Criteria:

  • Has neurological disorder other than dystonia (such as compressive neuropathy, limb trauma, epilepsy)
  • Cognitive deficits leading to inability to understand study purposes and risks as well as the consent information without legal trustee
  • Presence of metal implanted in body that is contraindicated in MRI
  • Pregnancy
  • Has a previous surgical intervention to treat CD such as lesioning or a DBS system in place
  • Major systemic illness or infection

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: LIFUS - GPi

Bilateral thetaburst LIFUS stimulation to globus pallidus

experimental: LIFUS - DN

Bilateral thetaburst LIFUS stimulation to dentate nucleus

sham comparator: LIFUS - Sham

Bilateral Sham LIFUS stimulation

Interventions

LIFUS - GPi Active

Bilateral thetaburst LIFUS stimulation to the globus pallidus

LIFUS - DN Active

Bilateral thetaburst LIFUS stimulation to dentate nucleus

LIFUS - Sham

Bilateral sham (placebo) LIFUS stimulation

Primary outcome measure

  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: from Visit 2 prior to stimulation to up to 2 weeks ]
  • Resting State Functional MRI [ Time Frame: from Visit 2 prior to stimulation to up to 1 week ]
  • Dystonia non-motor symptoms questionnaire (DNMSQuest) [ Time Frame: from Visit 2 prior to stimulation to up to 2 weeks ]

Central Contacts and Locations

Central contacts

Jean-Francois Nankoo, PhD

416-603-5792jean-francois.nankoo@uhn.ca

Julian Kwok

416-603-5800julian.kwok@uhn.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Julian Kwok

416-603-5800julian.kwok@uhn.ca

Principal Investigator:

Robert Chen, MD

More Information

Sponsor

Robert Chen

Last update posted

Jul 8, 2026

Last verified

Feb, 2026

Keywords

  • Cervical Dystonia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Robert Chen on 2026-07-08.