Recruiting

tPCS

Sponsor:

Western University, Canada

Code:

NCT05625620

Conditions

Cerebellar Ataxia

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Active Transcranial Pulse Current Stimulation

Sham Transcranial Pulse Current Stimulation

Study Details

Brief summary:

Neurodegenerative ataxia represents a group of disabling diseases. Patients mainly present with imbalance during walking, speech problem and difficulty in co-ordination during working with hands. No effective treatment is currently available for them. Currently, studies are going on the effectiveness of noninvasive brain stimulation (NIBS) in neurodegenerative diseases. It is a mode of brain stimulation technique where current is delivered into the brain by placing electrodes into their scalp. Transcranial pulsed current stimulation (tPCS) is a new modality of NIBS. . The clinical benefit observed after a single session of tPCS in 15 patients with neurodegenerative ataxia, suggest that prolonged stimulation could be even more effective. The investigator have planned to study the efficacy of long-term tPCS in these patients of neurodegenerative ataxia.

Patients will be first examined clinically by the researcher along with the Scale for the Assessment and Rating of Ataxia (SARA) and Cerebellar Cognitive Affective Syndrome Scale (CCAS). Upper limb motor function, speech and Gait will be assessed according to the established protocol.

After the screening visit and inclusion, all patients will be randomized into daily cerebello- spinal tPCS or sham stimulation.

Anodal stimulation will be used for cerebellum and cathodal stimulation for the spinal stimulation. 20 min of non-invasive stimulation will be given via tPCS either real or sham stimulation. Patients will be trained and tolerability and ability to self-administer tPCS at home will be determined. Patients will continue tPCS at home 20 min daily for 2 weeks (7 days/week for 2 weeks). Assessments will be carried out 2 weeks after the first intervention (either real or sham tPCS).Then, patients will be reassessed at 1-month and 3-months follow-ups. After a washout period of 3 months since the last visit, each patient will receive the opposite treatment and undergo the same standardized assessment as in the first phase.

Conditions

Cerebellar Ataxia

Study ID

NCT05625620

Start date

Jan, 2023

Status verified date

Nov, 2022

Completion date

Dec, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients diagnosed with neurodegenerative ataxia (clinically or by genetic study).

Exclusion Criteria:

  • Patients unable to walk even with support (wheelchair or bed bound patients for example)
  • Other comorbidities deemed by the investigators to interfere with clinical, motor, gait or qEEG assessments.
  • Patients with Pacemaker
  • Patients with metal implants in the head/neck region
  • Severe comorbidity
  • Intake of illegal drugs
  • Pregnancy
  • Patients unable to provide informed consent
  • Patients unable to communicate in English.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: Real tPCS

All patients will be randomized into daily cerebello- spinal tPCS or sham stimulation. Randomization will occur in a ratio of 1:1. Real tPCS arm will receive active tPCS. Then they will be crossed over to Sham tPCS arm.

experimental: Sham tPCS

All patients will be randomized into daily cerebello- spinal tPCS or sham stimulation. Randomization will occur in a ratio of 1:1. Sham tPCS arm will receive active tPCS. Then they will be crossed over to Real tPCS arm.

Interventions

Active Transcranial Pulse Current Stimulation

Active tPCS will be delivered through a pair of saline-soaked (0.9% NaCl) surface sponge electrodes (7 × 5 cm2, for the anodal cerebellar electrode; 8 × 6 cm2 for the cathodal spinal electrode). Anodal stimulation will be applied on the scalp over the cerebellum area (2 cm under the inion) and the cathode will be placed over the spinal lumbar enlargement (2 cm under T11). During anodal stimulation, a constant current of 2 mA will be applied for 20 minutes.

Sham Transcranial Pulse Current Stimulation

Sham tPCS will be delivered through a pair of saline-soaked (0.9% NaCl) surface sponge electrodes (7 × 5 cm2, for the anodal cerebellar electrode; 8 × 6 cm2 for the cathodal spinal electrode). Anodal stimulation will be applied on the scalp over the cerebellum area (2 cm under the inion) and the cathode will be placed over the spinal lumbar enlargement (2 cm under T11). During anodal stimulation, a constant current of 2 mA will be applied for 20 minutes. Electric Current will be ramped down 5 seconds after the beginning of the stimulation to make this condition indistinguishable from the experimental active stimulation.

Primary outcome measure

  • Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline after 2-week/daily tPCS [ Time Frame: Baseline - 2 weeks - 1 month - 3 months ]

Central Contacts and Locations

Central contacts

Mandar Jog, MD

519-685-8500jog@lhsc.on.ca

Gala Prado Miranda, MD

5196633814gala.pradomiranda@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Mandar Jog

Mandar.Jog@lhsc.on.ca

More Information

Sponsor

Western University, Canada

Last update posted

Nov 23, 2022

Last verified

Nov, 2022

Keywords

  • Non-invasive Stimulation
  • Transcranial Pulsed Current stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2022-11-23.