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

November 14, 2022 updated by: Mandar Jog, Western University, Canada

A Long Term At-home Trial With Cerebellar-spinal Transcranial Pulsed Current Stimulation (tPCS) for Treatment of Neurodegenerative Ataxia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigator have planned to study the efficacy of long-term tPCS in these patients of neurodegenerative ataxia. Anodal stimulation will be used for cerebellum and cathodal stimulation for the spinal stimulation.

After the screening visit and inclusion, all patients will be randomized into daily cerebello- spinal tPCS or sham stimulation. Randomization will occur in a ratio of 1:1. After a washout period of three months, all patients will be crossover to the other intervention. By the end of the study all patients will receive a cycle of tPCS and a cycle of sham stimulation. Clinical rater will be blinded throughout the whole study.

After screening and randomization, all patients will undergo a baseline clinical assessment. A blinded researcher will apply the Scale for the Assessment and Rating of Ataxia (SARA) and the Cerebellar Cognitive Affective Syndrome Scale (CCAS). Also will asses speech, gait, and upper limb motor function. Speech will be assessed according to the established protocol. Gait will be assessed via Gait Carpet. Upper limb motor function will be assessed by a robotic arm called KinArm. At the initial visit, the patient will be trained and tolerability and ability to self-administer tPCS at home will be determined.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.

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. For the sham condition, electrode position will be same, but 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.

Participant's speech will be recorded using a head-mounted microphone (AKG-c520) and a digital recording device (Zoom H4nPro) while performing the following calibrated tasks. Calibration involves a sound level meter placed at 15cm from the mouth while talker says 'ah' at 70dBA. The following speech tasks will be assessed-

  1. Prolonged 'ah'.
  2. Rapid repetitions of the sounds "puh", "tuh", and "kuh".
  3. Two productions of a sentence with selected speech sounds (s, sh, p, b, t, i, a, u, ae, ai). "She saw Patty buy two poppies."
  4. Two times louder production of a sentence with selected speech sounds. "She saw Patty buy two poppies."
  5. Repetition of a continuous vowel at normal and fast rates. 'eye-eye-eye-eye-eye' without making any voice breaks or pauses".
  6. Read aloud a section of a standard passage - standard rainbow passage
  7. Monologue. Talk for two minutes about an interesting vacation (or an interesting hobby or activity).

For gait, the Zeno walkway it will be used. The Zeno walkway will be used in conjunction with the ProtoKinetics Movement Analysis Software (PKMAS). This detects pressure data during gait, balance, and additional movement protocols.

For measuring upper limb movements, KinARM will be used which is the short form of a robotic device. The KinARM initially provides the patients with multiple points to reach in the screen and the patients would try to reach these points using the KinARM handle.

All quantitative data will be expressed in term of medians and interquartile range. For qualitative variables, data will be expressed in total numbers and proportions (percentages).

Quantitative results from every assessment (T0, T1, T2 and T3) will be compared between sham and real stimulation using the Wilcoxon signed-rank test for paired samples. For qualitative data, variables will be compared using the chi-square (χ 2) test or the Fisher's exact test when appropriate. For all analyses a p<0.05 was specified as statistically significant.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mandar Jog, MD
  • Phone Number: 33814 519-685-8500
  • Email: jog@lhsc.on.ca

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in spatiotemporal gait measures using objective gait analysis
Time Frame: Baseline - 2 weeks - 1 month - 3 months
The investigators 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
Baseline - 2 weeks - 1 month - 3 months
Change in speech
Time Frame: Baseline - 2 weeks - 1 month - 3 months
The investigators will use standardized speech protocol pre and post stimulation to assess speech
Baseline - 2 weeks - 1 month - 3 months
Change in upper limb co-ordination
Time Frame: Baseline - 2 weeks - 1 month - 3 months
The investigators will use KinArm pre and post stimulation to have objective measurement of upper limb co-ordination
Baseline - 2 weeks - 1 month - 3 months
Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline
Time Frame: Baseline - 2 weeks - 1 month - 3 months
CCAS/Schmahmann syndrome scale: 120 point scale, yielding a total score of 0 (most severe cognitive impairment) to 120 (no cognitive impairment).
Baseline - 2 weeks - 1 month - 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

November 14, 2022

First Posted (Actual)

November 23, 2022

Study Record Updates

Last Update Posted (Actual)

November 23, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121665

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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