Effects of Neurofeedback Training and tRNS on Attentional Deficits in Patients With Acquired Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorHospitales Nisa
About this trial
The goal of this study is to investigate new neuromodulation therapies for attention deficits following acquired brain injury. Brain damage can affect various domains, including motor and cognitive functions. However, cognitive deficits have many consequences on the functionality and independence of patients, and attention is an essential requirement for most of daily activities. After brain damage, cognitive rehabilitation is generally the first treatment option for attention deficits. Some studies have shown that cognitive rehabilitation is sometimes not very effective.For this reason, new therapies such as neuromodulation techniques are being investigated. Neurofeedback is a non-invasive neuromodulation therapy involving a type of computer-based training and learning, and some studies have shown that it is a promising tool to treat cognitive deficits in patients with brain injuries. Transcranial electrical stimulation (tES) is also used to modulate spontaneous brain activity. In the present study, the investigators will evaluate the effects of tES combined with neurofeedback as a therapy for attentional deficits after brain injury.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
ABI resulting from TBI, stroke, hypoxia and other etiologies
attentional deficits that are among the objectives of neurorehabilitation as established by the clinical team (scores falling in the 90% percentiles on the Conner's Continuous Performance - CCPT, on the Digit and Spatial Span Tasks and Color Trail test)
good cognitive condition (ie., scores of ≥23 in the Mini Mental State Examination
Disqualifiers
previous report of psychiatric and/or neurologic disorders
contraindication to computerized activities
blindness or severe visual impairments
Trial design
Design model
Parallel
Treatments tested in this trial
verum tRNS + Neurofeedback
DeviceThe neuromodulation intervention will have the following characteristics: each session will last 1 hour; 10 minutes of tRNS will precede 20 minutes of NF, with approximately 20 minutes for setting up the system and measuring impedances until the NF signal reaches optimal quality, and 10 minutes for removing the equipment. The tRNS will deliver a biphasic sinusoidal random noise current (tRNS) with an amplitude of 2 mA within the 16-25 Hz frequency range, using electrodes placed over F3 and F4. To administer tES, we will use a portable device from the Neurocare Group, which produces neuromodulation devices for research and clinical applications and has CE approval (Neurocare DC-STIMULATOR MOBILE). The NF will reinforce the 16-25 Hz frequency range and will consist of an EEG-based visual task, i.e., a video that decreases or increases in size according to the β levels detected at Fz. For NF, we will use a device from Thought Technology, the ProComp 2, together with Biograph Infinity
sham tRNS + Neurofeedback
DeviceThe intervention will have the following characteristics: each session will last 1 hour; 10 minutes of tRNS will precede 20 minutes of NF, with approximately 20 minutes for setting up the system and measuring impedances until the NF signal reaches optimal quality, and 10 minutes for removing the equipment. The sham tRNS will deliver a biphasic sinusoidal random noise current (tRNS) with for 30 seconds and then will automatically turn off. To administer tES, we will use a portable device from the Neurocare Group, which produces neuromodulation devices for research and clinical applications and has CE approval (Neurocare DC-STIMULATOR MOBILE). The NF will reinforce the 16-25 Hz frequency range and will consist of an EEG-based visual task, i.e., a video that decreases or increases in size according to the β levels detected at Fz. For NF, we will use a device from Thought Technology, the ProComp 2, together with Biograph Infinity
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Group A ( verum tRNS + NF)Active comparator 1 intervention
Group B: Group B (sham tRNS + NF)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Behavioral effectiveness of tRNS + NF on attention measures - CCPT
The Conners Continuous Performance Test (CCPT ) is a computer administered test designed to assess problems with attention. It presents 360 stimuli trials (i.e., individual letters) on the screen, with 1, 2, or 4 seconds intervals between the presentatio
Time frame
The CCPT will be assessed at baseline (pre-treatment, within two weeks before the start of the treatment) and at T1 (post-treatment assessment, within 3 weeks of the end of the treatment)2
Behavioral effectiveness of tRNS + NF on attention measures - Digit Span
The digit span test is a very short test that evaluates a person's cognitive status that initially was part of Wechsler's Intelligence Scale. It consists of telling the participant a series of numbers and ask him to repeat them back to you in the same order you say them. The first series are composed of three numbers, the next series four numbers, then five etc. The series are repeated until one incorrect answer is observed. Both the digit and spatial span tests are frequently used in hospitals and physicians' offices in order for a clinician to quickly evaluate whether a person's cognitive abilities are normal or impaired
Time frame
The Digit Span test will be assessed at baseline (pre-treatment, within two weeks before the start of the treatment) and at T1 (post-treatment assessment, within 3 weeks of the end of the treatment)3
Behavioral effectiveness of tRNS + NF on attention measures - D2-R
The d2-R measures the ability to concentrate and sustain attention. It consists of picking out target symbols, from among similar symbols, under pressure of time. The participant is asked to search for and mark certain target symbols (ie., the letter "d" with two dashes). The test itself consists of 14 screens in succession, each having 60 symbols laid out in six rows of ten. All instances of "d" with two dashes are to be marked. The instruction is to work quickly, without making mistakes.
Time frame
The D2-R test will be assessed at baseline (pre-treatment, within two weeks before the start of the treatment) and at T1 (post-treatment assessment, within 3 weeks of the end of the treatment)4
electrophysiological effectiveness of tRNS+ NF - EEG power and connectivity
EEG analyses are based on the recording of EEG signal, which is the sum of neuronal activity, mainly post-synaptic, represented on a time axis. Based on EEG we will be able to perform analyses on qEEG, connectivity between regions. We will use BrainVision system for EEG recording of 10 minutes of resting state (5 minutes eyes open, 5 minutes eyes closed).
Time frame
The EEG resting state will be assessed at baseline (pre-treatment, within two weeks before the start of the treatment) and at T1 (post-treatment assessment, within 3 weeks of the end of the treatment)Secondary outcomes
1
Motivation of tRNS + NF training compared to standard cognitive rehabilitation
The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments. It is composed of several subscales that measure enjoyment, perceived competence, effort, value, felt pressure, perceived choice. The interest/enjoyment subscale is the self-report measure of intrinsic motivation. Although research has showed that the order in which the subscales are presented is negligible, all subscales are rarely administered and researchers generally choose the subscales relevant to their study. In the present study we will administer the items related to the interest/enjoyment subscale.
Time frame
The IMI questionnaire will be filled in at T1 (post-intervention, within 3 weeks of the end of the treatment)2
Transfer to daily life and perceived effectiveness - PGIC
The Patient's Global Impression of Change is a short questionnaire composed of two questions about the patient's perception of change related to his/her symptoms. One question is rated 1 to 7 (Likert scale) and the other one is rated 0 to 10.
Time frame
The PGIC questionnaire will be provided to participants post-intervention (within 3 weeks of the end of the treatment)3
Side effects and adverse events of the intervention
We will collect information on possible side effects perceived during and after each session of intervention. Participants will be asked to report any side effect perceived during and after every session of intervention (both tRNS and NF).
Time frame
This information will be collected in the case report form during and after each sessionSponsors and contacts
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Source ClinicalTrials.gov