Effects of Cerebellar tACS-iTBS in Ataxia

NCT06420271 | Recruiting

• 1 other identifier: 80/SL/23
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Ataxia refers to a group of neurological disorders characterized by impaired coordination and balance due to dysfunction in the cerebellum or its connections. Traditional therapeutic approaches for ataxia have shown limited efficacy, prompting researchers to explore alternative interventions. Non-invasive brain stimulation (NIBS) techniques, such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and intermittent theta burst stimulation (iTBS), have emerged as potential therapeutic options. The aim of this study is to investigate the combined effect of tACS-iTBS on balance functions in ataxia disorders.

Conditions

Ataxia

Keywords

Non Invasive Brain Stimulation; Transcranial Magnetic Stimulation; Intermittent Theta Burst Stimulation; Transcranial Electrical Stimulation; Transcranial Alternating Current Stimulation; Exergaming

Outcome Measures

Primary Outcomes (1)

• Changes in the International Cooperative Ataxia Rating Scale (ICARS)

  ICARS was developed to quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Score ranges from 0 to 100 where 100 indicates severe ataxia.

  Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)

Secondary Outcomes (4)

• Changes in the Short Form-36 Health Survey (SF-36)

  Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)

• Changes in postural control

  Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)

• Changes in cortico-spinal excitability

  Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)

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

  Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)

Other Outcomes (1)

• Change in Cerebellar Brain Inhibition (CBI)

  Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)

Study Arms (2)

Real tACS + real iTBS + exergaming

EXPERIMENTAL

10 sessions of real 5Hz tACS with real iTBS + exergaming biofeedback, 5 times per weeks for two weeks.

Device: Real (real iTBS/tACS + exergaming)

Sham tACS + sham iTBS + exergaming

PLACEBO COMPARATOR

10 sessions of sham 5Hz tACS with sham iTBS + exergaming biofeedback, 5 times per weeks for two weeks.

Device: Sham (sham iTBS/tACS + exergaming)

Interventions

Real (real iTBS/tACS + exergaming) DEVICE

Stimulation will be applied to the cerebellum. The tACS session duration will be 190 seconds with a frequency of 5 Hz coupled with iTBS (coil positioned tangentially with respect to the scalp)(600 pulses consisting of bursts of 3 stimuli at 50 Hz, repeated at intervals of 200ms, with an intensity of 80% of active motor threshold -AMT-) (Huang et al., 2005) for a total duration of 190 seconds (repeated over both cerebellar hemispheres after a 15-minute rest period). The exergaming will be performed with an adaptive system, comprising a force platform connected to a computer. The system is designed to enhance standard balance rehabilitation programs by guiding the user's performance of prescribed physical exercises through a video interface. Patients will perform 3 different exercises (10 minutes of training for a total of 30 minutes): latero-lateral and antero posterior load shift, omnidirectional displacement (combined latero-lateral and antero-posterior loading).

Also known as: real iTBS/tACS + exergaming

Real tACS + real iTBS + exergaming

Sham (sham iTBS/tACS + exergaming) DEVICE

Stimulation will be applied to the cerebellum. The tACS session duration will be 10 seconds with a frequency of 5 Hz coupled with sham iTBS (coil positioned perpendicularly with respect to the scalp)(600 pulses consisting of bursts of 3 stimuli at 50 Hz, repeated at intervals of 200ms, with an intensity of 80% of active motor threshold -AMT-) (Huang et al., 2005) for a total duration of 190 seconds (repeated over both cerebellar hemispheres after a 15-minute rest period). The exergaming will be performed with an adaptive system, comprising a force platform connected to a computer. The system is designed to enhance standard balance rehabilitation programs by guiding the user's performance of prescribed physical exercises through a video interface. Patients will perform 3 different exercises (10 minutes of training for a total of 30 minutes): latero-lateral and antero posterior load shift, omnidirectional displacement (combined latero-lateral and antero-posterior loading).

Also known as: sham iTBS/tACS + exergaming

Sham tACS + sham iTBS + exergaming

Eligibility Criteria

• Age: 8 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of ataxia based on clinical assessment and/or neuroimaging findings.
• Stable medication regimen for at least four weeks prior to the study.
• Sufficient cognitive ability to understand and comply with study instructions.

You may not qualify if:

• History of seizures.
• Severe general impairment or concomitant diseases.
• Intracranial metal implants.
• Cardiac pacemaker.
• Pregnancy status.

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

IRCCS Santa Lucia Foundation

Rome, Lazio, 00179, Italy

RECRUITING

Related Publications (5)

• Spampinato D, Avci E, Rothwell J, Rocchi L. Frequency-dependent modulation of cerebellar excitability during the application of non-invasive alternating current stimulation. Brain Stimul. 2021 Mar-Apr;14(2):277-283. doi: 10.1016/j.brs.2021.01.007. Epub 2021 Jan 20.

  PMID: 33482375 BACKGROUND

• Libri I, Cantoni V, Benussi A, Rivolta J, Ferrari C, Fancellu R, Synofzik M, Alberici A, Padovani A, Borroni B. Comparing Cerebellar tDCS and Cerebellar tACS in Neurodegenerative Ataxias Using Wearable Sensors: A Randomized, Double-Blind, Sham-Controlled, Triple-Crossover Trial. Cerebellum. 2024 Apr;23(2):570-578. doi: 10.1007/s12311-023-01578-6. Epub 2023 Jun 22.

  PMID: 37349632 BACKGROUND

• Guerra A, Suppa A, Bologna M, D'Onofrio V, Bianchini E, Brown P, Di Lazzaro V, Berardelli A. Boosting the LTP-like plasticity effect of intermittent theta-burst stimulation using gamma transcranial alternating current stimulation. Brain Stimul. 2018 Jul-Aug;11(4):734-742. doi: 10.1016/j.brs.2018.03.015. Epub 2018 Mar 24.

  PMID: 29615367 BACKGROUND

• Gong C, Long Y, Peng XM, Hu H, Chen J, Xiao L, Zhong YB, Wang MY, Luo Y. Efficacy and safety of noninvasive brain stimulation for patients with cerebellar ataxia: a systematic review and meta-analysis of randomized controlled trials. J Neurol. 2023 Oct;270(10):4782-4799. doi: 10.1007/s00415-023-11799-8. Epub 2023 Jul 17.

  PMID: 37460852 BACKGROUND

• Spampinato DA, Pezzopane V, Cinnera AM, D'Arienzo M, Piatti D, Ferraresi M, Vinci AC, Colona VL, Vasco G, Grasso MG, Paolucci S, Bonni S, Koch G. Effects of combined cerebellar tACS-iTBS in individuals with ataxia (EtABeta): a crossover investigation. Trials. 2026 Mar 24. doi: 10.1186/s13063-026-09653-z. Online ahead of print.

  PMID: 41877266 DERIVED

MeSH Terms

Conditions

Ataxia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Danny Spampinato, PhD

  University of Roma La Sapienza

  STUDY CHAIR

• Alex Martino Cinnera, PhD

  IRCCS Santa Lucia Foundation

  STUDY CHAIR

Central Study Contacts

Giacomo Koch, Prof.

CONTACT

0651501181; g.koch@hsantalucia.it

Valentina Pezzopane, MSc

CONTACT

0651501181; v.pezzopane@hsantalucia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized cross-over design will be used. A 3-weeks wash-out period will be observed between the two conditions (real and sham).

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)