Transcranial Alternating Current for Oscillopathies

NCT03221413 | Completed

• 1 other identifier: UPadova
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The need for non-invasive, non-pharmacological and cost-effective therapeutic options has revived the use of transcranial current stimulation, either direct (tDCS) or alternating (tACS), in a wide range of pathologies and cognitive disturbances. Results, although often promising, are not unequivocal, possibly due to different stimulation parameters and sites, or non-homogenous patient selection. tDCS has been widely applied but few studies have focused on tACS which has the advantage of potentially entraining brain oscillations at the same frequency of stimulation. This overcomes the basic mechanism of tDCS which deploys anodal or cathodal currents to broadly excite or inhibit supposedly dysfunctional underlying cortex. Whether a stimulation paradigm based on sound neurophysiological markers could provide a better and longer-lasting clinical outcome has not yet been ascertained. The investigators aim to establish, with a trans-disease approach, categories characterized by defective EEG oscillatory activity and related dysfunctional networks. This classification, expected as the result of the first stage of this project, will guide the stimulation paradigm: categories with a pathologically low-band EEG prevalence will be treated with high-frequency tACS, and vice-versa, while the stimulation site will correspond to the defective sites of pathological EEG band maps. Parkinson's disease (PD), the EEG marker of which is a shift towards fast frequencies, and neuropathic pain (NP), with an EEG prevalence of slow bands, will be considered. In order to categorize pathologies on the basis of their EEG frequencies, EEG power spectrums will be derived from resting EEG, and cortical oscillatory reactivity will be assessed by EEG-TMS (electroencephalographic-Transcranial Magnetic Stimulation) co-registration. This method appears to elicit state-dependent brain oscillatory response and is expected to support power spectrum data. The identified prevailing EEG band will be used subsequently to reconstruct scalp EEG band distribution. tACS paradigms will be tailored according to these findings: the anode will be placed over the scalp area corresponding to the dysfunctional rhythm and frequency will be set in order to correct the prevailing EEG band (slow stimulation if fast frequencies prevail, and vice-versa). The translational element of this research proposal will consist of its clinical application in day-to-day practice for the benefit of people with the target conditions. The patient-groups, after undergoing the neurophysiology studies, will be tested with disease-specific scales and a neuropsychological battery. A 2-weeks tACS, either real or active sham, protocol will then be performed (30 minutes/day, 5 days/week), associated with an ad hoc rehabilitation protocol (60 minutes/day 5 days/week). During the last day of stimulation, patients will be tested again with the disease specific scales, neuropsychological battery and standard EEG to detect EEG frequencies modifications. At 4-weeks follow up, the same tests and EEG recording will be carried out, to assess the persistence of after-effects. The expected result is a valid, non-invasive and cost-effective stimulation paradigm based on sound neurophysiologic markers which transcend traditional disease classifications.

Conditions

Parkinson Disease; Pain

Keywords

transcranial alternating current stimulation; Neuroimaging; EEG

Outcome Measures

Primary Outcomes (4)

• Proportion of people displaying fast brain oscillatory activity [measured as electroencephalographic (EEG) beta band prevalence]

  EEG power spectral maps will identify this category

  1 year (first)

• Proportion of people dispalying slow brain oscillatory activity [measured as electroencephalographic (EEG) theta band prevalence]

  EEG power spectral maps will identify this category

  1 year (first)

• Improvement ≥ 30% of the total off-medication on a motor performance scale (Unified Parkinson's Disease Rating Scale,part III)

  UPDRS III is a scale measures motor preformance specifically in Parkinson's Disease

  1 to 2 years (2nd year)

• Pain reduction, measured with a specific scale (NPQ-Neuropathic Pain Questionnaire), as a reduction of at least 4 points

  NPQ (Neuropathic Pain Questionnaire) is a scale measures pain

  1 to 2 years (2nd year)

Secondary Outcomes (4)

• Modifications of frequencies of oscillatory brain activity, measured as spectral power modifications (prevalence of electroencefalographic frequencies) between T0 and T1 and T1 and T2

  1 to 2 years (2nd year)

• Neuropsychological testing: improvement between T0 and T1 and T1 and T2.

  1 to 2 years (2nd year)

• Mean change in visual analogue scale (VAS) for pain

  1 to 2 years (2nd year)

• Mean change in Short Form (36) Health Survey for NP

  1 to 2 years (2nd year)

Study Arms (2)

PD tACS

EXPERIMENTAL

Persons with Parkinson disease who will be treated with tACS: Intervention: tACS (transcranial alternating current stimulation)

Device: transcranial alternating current stimulation (tACS)

Pain tACS

EXPERIMENTAL

Persons with neuropathic pain who will treated with tCAS. Intervention: tACS (transcranial alternating current stimulation)

Device: transcranial alternating current stimulation (tACS)

Interventions

transcranial alternating current stimulation (tACS) DEVICE

PD tACS; Pain tACS

Eligibility Criteria

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

You may qualify if:

• PD: diagnosis of idiopathic PD within the last 5 years (UK Brain Bank criteria); stable dose of antiparkinson therapy for at least 4 weeks; total off-medication motor Hoen and Yahr 1-2.
• NP: stable chronic pain for at least the preceding six months; score greater than or equal to 3 (0 no pain, 10 worst pain) on the visual analog scale (VAS) for pain perception during the last month before start of stimulation; refractoriness to drugs for pain relief (pain resistance to at least two of these drugs supplied in adequate dosages for 6 months).

You may not qualify if:

• PD: concomitant psychiatric disorder; benzodiazepine treatment; Mini Mental State Examination (MMSE) \<26
• NP: clinically significant or unstable medical or psychiatric disorder, history of substance abuse

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University Hospital

Padua, 35128, Italy

Location

Related Publications (1)

• Del Felice A, Castiglia L, Formaggio E, Cattelan M, Scarpa B, Manganotti P, Tenconi E, Masiero S. Personalized transcranial alternating current stimulation (tACS) and physical therapy to treat motor and cognitive symptoms in Parkinson's disease: A randomized cross-over trial. Neuroimage Clin. 2019;22:101768. doi: 10.1016/j.nicl.2019.101768. Epub 2019 Mar 18.

  PMID: 30921609 RESULT

MeSH Terms

Conditions

Parkinson Disease; Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Alessandra Del Felice, PhD

  University of Padua, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: July 18, 2017
• Study Start: May 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: March 31, 2019
• Last Updated: April 30, 2021

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: ORCID Registered scientists at any time

Locations

IT (1)