A Study on Cerebello-Spinal tPCS in Ataxia

NCT04054726 | Unknown

• 1 other identifier: 113969
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cerebellar ataxia; Non-invasive stimulation; Transcranial pulsed current stimulation

Outcome Measures

Primary Outcomes (5)

• Change in Ataxia rating scale

  We will evaluate the effectiveness of tPCS in patients of neurodegenerative ataxia. We will apply Scale for the assessment and rating of ataxia (SARA) for rating of ataxia pre and post stimulation. The scale is for assessing severity of ataxia, that consists of assessment of gait, stance, sitting, speech, finger chase, finger to nose test, fast alternating hand movement, heel-shin test. By summing up, the total score ranges from minimum 0 and maximum 36. Higher score means more severity.

  3 months

• Changes in spatiotemporal gait measures using objective gait analysis

  We will use Zeno Walkway Gait carpet and the spatiotemporal details of the gait will be analyzed by ProtoKinetics Movement Analysis Software (PKMAS) software, pre and post stimulation.

  3 months

• Change in upper limb co-ordination

  We will use KinArm pre and post stimulation to have objective measurement of upper limb co-ordination.

  3 months

• Change in speech

  We will use standardized speech protocol pre and post stimulation to assess speech.

  3 months

• Changes in Network fragmentation using Quantitative EEG

  We will do network fragmentation by 5 mins of resting quantitative Electroencephalography (EEG), pre and post stimulation.

  3 months

Study Arms (2)

Real tPCS

EXPERIMENTAL

Patients of degenerative ataxia will be randomly allocated into both the arms. Real tPCS arm will receive active tPCS. Then they will be crossed over to Sham tPCS arm.

Device: Active Transcranial pulsed current stimulation (tPCS)

Sham tPCS

SHAM COMPARATOR

Patients of degenerative ataxia will be randomly allocated into both the arms. Sham tPCS arm will receive sham tPCS. Then they will be crossed over to Real tPCS arm.

Device: Sham Transcranial pulsed current stimulation (tPCS)

Interventions

Active Transcranial pulsed current stimulation (tPCS) DEVICE

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.

Real tPCS

Sham Transcranial pulsed current stimulation (tPCS) DEVICE

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.

Sham tPCS

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed as neurodegenerative ataxia clinically or by genetic study.

You may not qualify if:

• Patients who can't walk even with support, like wheel chair bound patients.
• Patients having other issues like stroke that can aggravate speech/ gait.
• Patients who are not able to provide informed consent.
• Patients who are unable to communicate by speech and who can't comprehend the English language.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (4)

• Benussi A, Dell'Era V, Cantoni V, Bonetta E, Grasso R, Manenti R, Cotelli M, Padovani A, Borroni B. Cerebello-spinal tDCS in ataxia: A randomized, double-blind, sham-controlled, crossover trial. Neurology. 2018 Sep 18;91(12):e1090-e1101. doi: 10.1212/WNL.0000000000006210. Epub 2018 Aug 22.

  PMID: 30135258 BACKGROUND

• Alon G, Yungher DA, Shulman LM, Rogers MW. Safety and immediate effect of noninvasive transcranial pulsed current stimulation on gait and balance in Parkinson disease. Neurorehabil Neural Repair. 2012 Nov-Dec;26(9):1089-95. doi: 10.1177/1545968312448233. Epub 2012 May 10.

  PMID: 22581566 BACKGROUND

• Grimaldi G, Manto M. Anodal transcranial direct current stimulation (tDCS) decreases the amplitudes of long-latency stretch reflexes in cerebellar ataxia. Ann Biomed Eng. 2013 Nov;41(11):2437-47. doi: 10.1007/s10439-013-0846-y. Epub 2013 Jun 19.

  PMID: 23780473 BACKGROUND

• Maas RPPWM, Toni I, Doorduin J, Klockgether T, Schutter DJLG, van de Warrenburg BPC. Cerebellar transcranial direct current stimulation in spinocerebellar ataxia type 3 (SCA3-tDCS): rationale and protocol of a randomized, double-blind, sham-controlled study. BMC Neurol. 2019 Jul 4;19(1):149. doi: 10.1186/s12883-019-1379-2.

  PMID: 31272408 BACKGROUND

MeSH Terms

Conditions

Cerebellar Ataxia

Condition Hierarchy (Ancestors)

Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ataxia; 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

‪519-685-8500‬; Mandar.Jog@lhsc.on.ca

Study Design

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

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 13, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)