Trans-spinal Electrical Stimulation in Individuals With Spinocerebellar Ataxia

NCT06267222 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: SCATDCS23
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this pragmatic clinical trial is to investigate the effects of trans-spinal tDCS in individuals with spinocerebellar ataxia (SCA) over some parameters of gait and postural control in real-world conditions, reflecting daily clinical practice. The main questions it aims to answer are:

• If an extended number of tDCS sessions, beyond the typical 5 to 10 sessions described in scientific literature, applied concomitantly with exercises with progressive challenges, to yield positive outcomes over some parameters of gait and postural control in individuals with SCA and if there is retention of possible benefits one month later the end of this protocol.
• If there is specific characteristics (including balance, gait, mobility, severity of ataxia, DNA test characteristics and non-ataxic signs) in individuals with SCA that can predict their improvement in postural control and gait following the 20 tDCS sessions.
• Participants will receive 20 tDCS sessions concomitantly with exercises for gait and postural control with progressive challenges.
• Postural control and gait of the participants will be assessed in two big sessions before (#assessment 1) and after the 20 sessions (#assessment 5) and 3 small sessions after every 5 sessions (#assessments 2, 3 and 4). Also, as a follow-up, they will be assessed a month after the end of the intervention (#assessment 6).

Conditions

SCA; Postural Balance; Gait Ataxia

Keywords

NIBS; TRANS-SPINAL STIMULATION; CEREBELLAR ATAXIA

Outcome Measures

Primary Outcomes (4)

• Postural control

  The Berg Balance Scale (BBS) measures functional balance and fall risk in 14 tasks. Each item is given a score of 0-4, with a total score between 0 and 56, being the higher the score, the better the individual's performance. The Berg scale also predicts the risk of falls. A score equal to or less than 45 points indicates a greater risk of falls. The four-stage test (4-stage) assesses static balance and measures an individual's ability to hold a series of four balance positions, each more challenging than the previous, for at least 10 seconds each.

  (i) Baseline, (ii) after 20 sessions and (iii) in follow up (one month).

• Mobility

  Timed up and go (TUG) assesses mobility, balance, walking ability and the risk of falling. On the command "go", the patient gets up from the chair, walks 3 meters, turns around, returns to the chair, and sits down. The time is calculated in seconds. The longer the time taken, the greater the risk of falling

  (ii) Baseline, (ii) at the end of sessions 5, 10, 15 and 20 (each session is 1 day) and (iii) in follow up (one month)

• Gait performance

  Measured by the Modified Dynamic Gait Index (mDGI) which total score is from 0 (severe gait impairment) to 64 (no gait impairment) and a Ten-meter walk test with an accelerometer fixed at the sacrum to assess step and stride time, speed, and gait cadence.

  (ii) Baseline, (ii) at the end of sessions 5, 10, 15 and 20 (each session is 1 day) and (iii) in follow up (one month)

• Accelerometry

  To perform three tasks using an accelerometer of a mobile phone fixed on the participant's waist: (i) 5 times sit-to-stand; (ii) Functional Reach Test; and (iii) a test consisted in move arms and head standing with foot together. The accelerometer will register how the body is moving and changing speed over time while performing tasks.

  (i) Baseline and (ii) after 20 sessions.

Secondary Outcomes (2)

• The subjective experience of the participants regarding the protocol.

  At the end of session 20 (each session is 1 day)

• The presence of non ataxic signals (INAS) and the disease severity (SARA)

  (i) Baseline and (ii) after 20 sessions.

Study Arms (1)

TRANS-SPINAL STIMULATION IN SCA

EXPERIMENTAL

The tDCS sessions will be conducted with an intensity of 2mA, utilizing the anodic electrode positioned over the cerebellar region and the cathodic electrode over the thoracic region of the spinal cord (approximately at vertebra T11). These sessions will be integrated into a gait and postural control training protocol, which will progressively increase in difficulty over 4 consecutive weeks on weekdays, excluding weekends. A total of 20 sessions will be administered, each lasting approximately 30 minutes. During each session, the electrodes will be placed, and participants will perform a single leg test on each side of the body. The exercise protocol will then be executed while the tDCS is applied, lasting for 20 minutes. Following the exercise, the single-leg test will be repeated, and the electrodes will be removed.

Device: TRANSCRANIAL DIRECT CURRENT STIMULATION + exercises

Interventions

TRANSCRANIAL DIRECT CURRENT STIMULATION + exercises DEVICE

Participants with SCA will receive trans-spinal tDCS and exercises. There will be no control group or sham stimulation. All participants will receive real tDCS stimulation

Also known as: tDCS and exercises

TRANS-SPINAL STIMULATION IN SCA

Eligibility Criteria

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

You may qualify if:

• Individuals aged 18 to 70, without distinction of gender or ethnicity;
• Diagnosed with spinocerebellar ataxia, of any type, by a neurologist;
• With mild to moderate ataxia severity;
• Able to walk 2 meters even when using a walker, cane or crutch;
• Score ≥21 (BERTOLUCCI et al., 1994) on the Mini-Mental State Examination (MMSE; FOLSTEINet al., 1975; ALMEIDA, 1998);
• No other concomitant neurological changes.

You may not qualify if:

• Illiterate;
• Being subjected to any other experimental physiotherapeutic or medicinal intervention during the clinical trial;
• Skin condition that may affect the electrode placement site
• Musculoskeletal, neurological or cardiorespiratory disorders that prevent the tests from being carried out;
• Epilepsy;
• Pregnancy;
• History of brain surgery;
• History of seizures;
• Metallic implants in the skull that interfere with neuromodulation;

Sponsors & Collaborators

• Laura Alice Santos de Oliveira: lead
• Federal Institute of Rio de Janeiro: collaborator

Study Sites (1)

Instituto de Neurologia Deolindo Couto

Rio de Janeiro, Rio de Janeiro, 22290-140, Brazil

Location

Related Publications (19)

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MeSH Terms

Conditions

Gait Ataxia; Cerebellar Ataxia

Interventions

Transcranial Direct Current Stimulation; Exercise Therapy

Condition Hierarchy (Ancestors)

Ataxia; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Gait Disorders, Neurologic; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities

Study Officials

• LAURA OLIVEIRA, PT PHD

  Centro Universitário Augusto Motta

  STUDY DIRECTOR

• ANNA FONTES BAPTISTA, PT

  Centro Universitário Augusto Motta

  PRINCIPAL INVESTIGATOR

• Eduardo S Moreira, PT

  Centro Universitário Augusto Motta

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: THE INVESTIGATOR NOT BE INFORMED ABOUT THE TREATMENT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: This is a pragmatic clinical trial that will be carried out using the CONSORT-Pragmatic Trials (Zwarenstein et al., 2008).

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: February 20, 2024
• Study Start: May 9, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)