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

NCT05625620 | Unknown

• 1 other identifier: 121665
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Non-invasive Stimulation; Transcranial Pulsed Current stimulation

Outcome Measures

Primary Outcomes (1)

• Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline after 2-week/daily tPCS

  The investigators will evaluate the effectiveness of tPCS in patients of neurodegenerative ataxia applying the Scale for the Assessment and Rating of Ataxia (SARA) 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. The total score ranges from 0( no ataxia) to 36(most severe ataxia).

  Baseline - 2 weeks - 1 month - 3 months

Secondary Outcomes (4)

• Changes in spatiotemporal gait measures using objective gait analysis

  Baseline - 2 weeks - 1 month - 3 months

• Change in speech

  Baseline - 2 weeks - 1 month - 3 months

• Change in upper limb co-ordination

  Baseline - 2 weeks - 1 month - 3 months

• Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline

  Baseline - 2 weeks - 1 month - 3 months

Study Arms (2)

Experimental: Real tPCS

EXPERIMENTAL

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.

Device: Active Transcranial Pulse Current Stimulation

Sham tPCS

EXPERIMENTAL

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.

Device: Sham Transcranial Pulse Current Stimulation

Interventions

Active Transcranial Pulse Current Stimulation 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). 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.

Experimental: Real tPCS

Sham Transcranial Pulse Current Stimulation 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). 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.

Sham tPCS

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

Related Publications (8)

• Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.

  PMID: 28709880 BACKGROUND

• Manto M, Gandini J, Feil K, Strupp M. Cerebellar ataxias: an update. Curr Opin Neurol. 2020 Feb;33(1):150-160. doi: 10.1097/WCO.0000000000000774.

  PMID: 31789706 RESULT

• Kim JS, Cho JW. Hereditary Cerebellar Ataxias: A Korean Perspective. J Mov Disord. 2015 May;8(2):67-75. doi: 10.14802/jmd.15006. Epub 2015 May 31.

  PMID: 26090078 RESULT

• Benussi A, Pascual-Leone A, Borroni B. Non-Invasive Cerebellar Stimulation in Neurodegenerative Ataxia: A Literature Review. Int J Mol Sci. 2020 Mar 12;21(6):1948. doi: 10.3390/ijms21061948.

  PMID: 32178459 RESULT

• Benussi A, Dell'Era V, Cotelli MS, Turla M, Casali C, Padovani A, Borroni B. Long term clinical and neurophysiological effects of cerebellar transcranial direct current stimulation in patients with neurodegenerative ataxia. Brain Stimul. 2017 Mar-Apr;10(2):242-250. doi: 10.1016/j.brs.2016.11.001. Epub 2016 Nov 3.

  PMID: 27838276 RESULT

• Ganguly J, Murgai A, Sharma S, Aur D, Jog M. Non-invasive Transcranial Electrical Stimulation in Movement Disorders. Front Neurosci. 2020 Jun 5;14:522. doi: 10.3389/fnins.2020.00522. eCollection 2020.

  PMID: 32581682 RESULT

• 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 RESULT

• 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 RESULT

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

Central Study Contacts

Mandar Jog, MD

CONTACT

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

Gala Prado Miranda, MD

CONTACT

5196633814; gala.pradomiranda@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

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 23, 2022
• Study Start: January 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)