Effects of Cerebellar tACS-iTBS in Ataxia
ConditionAtaxia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-80
SponsorI.R.C.C.S. Fondazione Santa Lucia
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of seizures.
Severe general impairment or concomitant diseases.
Intracranial metal implants.
Cardiac pacemaker.
Trial design
Design model
Crossover
Treatments tested in this trial
Real (real iTBS/tACS + exergaming)
DeviceStimulation 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).
Sham (sham iTBS/tACS + exergaming)
DeviceStimulation 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).
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Real tACS + real iTBS + exergamingExperimental treatment 1 intervention
Group B: Sham tACS + sham iTBS + exergamingPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)Secondary outcomes
1
Changes in the Short Form-36 Health Survey (SF-36)
SF-36 is an outcome measure instrument that is often used, well-researched, self-reported measure of health. Scores range from 0 to 100 for each domain, where 100 indicates a more favorable health-state.
Time frame
Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)2
Changes in postural control
Instrumented postural stability will be assessed using a 75 cm (length x width) static force platform (PlatformBPM 120, Physical Support Italia, Italy). The signals will be amplified and acquired using dedicated software (Physical Gait Software Vv. 2.66, Physical SupportItalia, Italy). The length of the center of pressure (CoP) trajectory (mm) will be measured as indicator of the postural stability. An increase in the length of CoP indicates a severe impairment in postural control.
Time frame
Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)3
Changes in cortico-spinal excitability
Twenty Motor evoked potentials (MEPs) will be collected from left and right primary motor cortex with single pulses of transcranial magnetic stimulation (TMS) set at 1 mV. An increase in the MEPs amplitude indicates an improvement in cortico-spinal activity recorded from the first dorsal interosseous and tibialis anterior muscles.
Time frame
Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)4
Change in the Scale for the Assessment and Rating of Ataxia (SARA)
SARA is a clinical scale developed to assess a range of different impairments in cerebellar ataxia. The scale is made up of 8 items related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test. Score ranges from 0 to 40 where 40 indicates severe ataxia.
Time frame
Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)Other outcomes
1
Change in Cerebellar Brain Inhibition (CBI)
CBI will be performed with two Magstim figure-of-eight coils (70 mm diameter), one placed over the primary motor cortex and the other centered over the contralateral cerebellar hemisphere, 1 cm below and 3 cm lateral to the Inion with an upward current induced to the brain. For each CBI evaluation, we will record 20 TMS test stimuli (TS) over the M1 that were set at intensity to elicit an MEP ∼1 mV. In half of these trials, selected randomly, a TMS conditioning stimulus (CS) was delivered over the contralateral cerebellar hemisphere 5 ms prior to the TS at an intensity of 120% of the resting motor threshold (RMT). Thus, a total of 20 TS and 20 CS + TS pulses will be administered. CBI will be calculated as the ratio of the mean MEP amplitude in the CS + TS relative to TS. An increase in CBI indicates higher connectivity between the cerebellum and primary motor cortex.
Time frame
Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2)Sponsors and contacts
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Source ClinicalTrials.gov