Clinical trial NCT06420271: Effects of Cerebellar tACS-iTBS in Ataxia
Official title: Effects of Combined Transcranial Electrical and Magnetic Stimulation of Cerebellum on Balance Function in Ataxia Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ataxia
Keywords: Non Invasive Brain Stimulation
Transcranial Magnetic Stimulation
Intermittent Theta Burst Stimulation
Transcranial Electrical Stimulation
Transcranial Alternating Current Stimulation
Exergaming
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized cross-over design will be used. A 3-weeks wash-out period will be observed between the two conditions (real and sham).
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. History of seizures.
2. Severe general impairment or concomitant diseases.
3. Intracranial metal implants.
4. Cardiac pacemaker.
5. Pregnancy status.

Primary outcomes:
measure: Change in the Scale for the Assessment and Rating of Ataxia (SARA)
timeFrame: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
measure: Changes in the Modified International Cooperative Ataxia Rating Scale (MICARS)
timeFrame: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
Secondary outcomes:
measure: Changes in the Short Form-36 Health Survey (SF-36)
timeFrame: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
measure: Changes in postural control
timeFrame: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
measure: Changes in cortico-spinal excitability
timeFrame: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
measure: Change in Cerebellar Brain Inibition (CBI)
timeFrame: Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)
Other outcomes:
Locations:
Study officials:
affiliation: University of Roma La Sapienza
name: Danny Spampinato, PhD
role: STUDY_CHAIR
affiliation: IRCCS Santa Lucia Foundation
name: Alex Martino Cinnera, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.