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NCT06267222
Trans-spinal Electrical Stimulation in Individuals With Spinocerebellar Ataxia
NA trial testing TRANSCRANIAL DIRECT CURRENT STIMULATION + exercises in SCA in 45 participants. Enrolling by invitation.
30 June 2024
Quick facts
| Lead sponsor | Laura Alice Santos de Oliveira |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 9 May 2024 |
| Primary completion | 30 June 2024 |
| Estimated completion | 31 July 2024 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- TRANSCRANIAL DIRECT CURRENT STIMULATION + exercises
Conditions studied
- SCA — all drugs for SCA →
- Postural Balance — all drugs for Postural Balance →
- Gait Ataxia — all drugs for Gait Ataxia →
Sponsor
Laura Alice Santos de Oliveira
Who can join
Adults 18 to 70, any sex, with SCA or Postural Balance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT06267222
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06267222 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Laura Alice Santos de Oliveira
- Last refreshed: 10 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06267222.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing