NCT06974149

Brief Summary

The aim of this study is to evaluate the effects of . Transcranial direct current stimulation (tDCS) combined with neurofunctional rehabilitation on disease severity in individuals with neurodegenerative ataxias. The study will compare whether the Neurofunctional Rehabilitation Protocol combined with real tDCS will bring better results in reducing disease severity compared to the neurofunctional rehabilitation protocol combined with simulated tDCS.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
34mo left

Started Jul 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Jul 2025Feb 2029

First Submitted

Initial submission to the registry

April 24, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

July 7, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

April 24, 2025

Last Update Submit

March 11, 2026

Conditions

Ataxias Espinocerebelares

Keywords

Ataxias espinocerebelaresestimulação transcraniana por corrente contínuareabilitação neurológica

Outcome Measures

Primary Outcomes (1)

  • Scale for the Assessment and Rating of Ataxia (SARA)

    The severity of ataxia will be assessed using the Ataxia Rating and Assessment (SARA) scale, which consists of eight items: gait, posture, sitting, speech, finger-chasing, nose-finger test, rapid alternation of hand movements, and lower limb coordination. The higher the score, the greater the severity of the disease.

    baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)

Secondary Outcomes (8)

  • Mini-BEST test

    baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)

  • Stabilometry

    baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)

  • Falls Efficacy Scale-International (FES-I)

    baseline, at the end of 5,10 and 20 sessions and follow up ( 2 and 4 months)

  • Timed Up and Go (TUG)

    baseline, at the end of 5 ,10 and 20 sessions and follow up ( 2 and 4 months)

  • 8-meter walk test (8mWT)

    baseline, at the end of 5,10 and 20 sessions and follow up ( 2 and 4 months)

  • +3 more secondary outcomes

Study Arms (2)

transcranial direct current stimulation associated with neurofunctional rehabilitation

ACTIVE COMPARATOR
Other: Neurofunctional RehabilitationDevice: transcranial direct current stimulation

transcranial direct current stimulation simulated associated with neurofunctional rehabilitation

SHAM COMPARATOR
Other: Neurofunctional RehabilitationDevice: transcranial direct current stimulation

Interventions

Neurofunctional RehabilitationOTHER

Neurofunctional Rehabilitation Protocol will consist of balance, motor coordination and gait exercises for 40 minutes and associated with tdcs

transcranial direct current stimulation associated with neurofunctional rehabilitation
transcranial direct current stimulationDEVICE

Transcranial direct current stimulation will be applied for 20 minutes at an intensity of 2 mA. The anode will be placed on the scalp over the cerebellar area (2 cm below the inion); the cathode, in turn, will be placed on the spinal column in the lumbar enlargement (2 cm below T11)

transcranial direct current stimulation associated with neurofunctional rehabilitation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of spinocerebellar ataxias;
  • Walking independently or with aids;

You may not qualify if:

  • Metal implants in the brain or spinal column and Cochlear implants;
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurocer

Porto Alegre, Rio Grande do Sul, 90430-150, Brazil

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 15, 2025

Study Start

July 7, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2029

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

BR(1)