Therapeutic efficacy of home-based long-term cerebellar transcranial direct current stimulation on cerebellar ataxia

Randomized, double-blinded, multi-center, prospective clinical trial for therapeutic efficacy of home-based long-term cerebellar transcranial direct current stimulation on cerebellar ataxia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0006626

Enrollment

Registered

2021-09-30

Start date

2021-10-04

Completion date

Unknown

Last updated

2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : For 23 cerebellar ataxia patients assigned to real stimulation group, cerebellar tDCS (2mA) is delivered for 20 minutes/day for 84 consecutive days (12 weeks). For 23 cerebellar atax

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age ranging from 30 to 69 years old 2. Patients with cerebellar ataxia, diagnosed as multisystem atrophy-cerebellar type, spinocerebellar ataxia, idiopathic late onset cerebellar ataxia 3. K-MMSE >=24 4. Unassisted gait (for more than 10 m) 5. Voluntarily signed up for the clinical trial

Exclusion criteria

Exclusion criteria: 1. Presence of medical or neurological disorders, or head trauma history 2. Presence of cognitive dysfunction affecting the ability to understand informed consent or perform the clinical trial 3. Presence of any suicidal idea or psychiatric disorders 4. Contraindication for tDCS (e.g. metallic device inserted in head) 5. Presence of skin problem hindering electrode adherence 6. Possibility of pregnancy 7. Pregnant state 8. Other reasons that are considered unsuitable for study enrollment

Design outcomes

Primary

Measure	Time frame
International Cooperative Ataxia Rating Scale (ICARS)	—

Secondary

Measure	Time frame
temporospatial parameters from GAITRite/Pedoscan;Montreal Cognitive Assessment/Korean Cerebellar Cognitive Affective/Schmahmann Syndrome scale (MoCA/K-CCAS);Beck Depression Inventory/Beck Anxiety Inventory (BDI/BAI);connectivity/integrity parameters from functional MR/diffusion tensor image;after-effect of tDCS (ICARS, GAITRite/Pedoscan, MoCA/K-CCAS, BAI/BDI);safety evaluation (adverse event)	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Eun Huh

Bundang CHA General Hospital

nana1880@hanmail.net+82-31-780-5486

Outcome results