Cerebellar-spinal Transcranial Pulsed Current Stimulation (tPCS) for Treatment of Neurodegenerative Ataxia

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

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Western University, Canada

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-31

Primary Completion

2024-06-30

Completion

2024-12-31

Countries

• Canada

Study Locations