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A Study on Cerebello-Spinal tPCS in Ataxia

NCT04054726 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-08-14

No results posted yet for this study

Summary

Neurodegenerative ataxia represents a group of disabling diseases. No effective treatment is currently available for them. Currently, studies are going on the effectiveness of noninvasive neurostimulation in neurodegenerative diseases. Transcranial pulsed current stimulation (tPCS) is a new modality of noninvasive neurostimulation. The investigators have planned to study the efficacy of tPCS in these patients of neurodegenerative ataxia.

Patients will be first examined clinically along with the rating of ataxia, assessment of upper limb coordination and speech as per protocol. Quantitative Electroencephalography (qEEG) and gait analysis will be done as per protocol. Next, a single session of 20 min non-invasive stimulation will be given via tPCS or sham stimulation. Stimulation will be given to cerebellum and dorsal spinal cord. After 20 mins of stimulation, re-assessment will be done using the same tools mentioned pre-stimulation.

Conditions

  • Cerebellar Ataxia

Interventions

DEVICE

Active Transcranial pulsed current stimulation (tPCS)

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). Anode will be placed on the scalp over the cerebellum area (2 cm under the inion). Cathode will be placed over the dorsal cord. Stimulation will be given for 20 mins.

DEVICE

Sham Transcranial pulsed current stimulation (tPCS)

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). Anode will be placed on the scalp over the cerebellum area (2 cm under the inion). Cathode will be placed over the dorsal cord. The 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

Principal Investigators

  • Mandar Jog, MD · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2021-09-30
Completion
2021-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04054726 on ClinicalTrials.gov