Effects of Neurofeedback Training and tRNS on Attentional Deficits in Patients With Acquired Brain Injury (NeMoRe II)
2026년 9월 11일 업데이트: Enrique Noe, Hospitales Nisa
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.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Alice Barra, PhD
- 전화번호: +34 625937357
- 이메일: alice.barra@irenea.es
연구 장소
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Valencia
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Valencia, Valencia, 스페인, 46007
- 모병
- Hospitales Vithas
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연락하다:
- Alice Barra
- 전화번호: + 34 625937357
- 이메일: alice.barra@irenea.es
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연락하다:
- Maria Dolores Navarro
- 이메일: lolesnavarro@gmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- ≥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
- MMSE or ≥75 in the Galveston Orientation & Amnesia Test - GOAT)
Exclusion Criteria:
- previous report of psychiatric and/or neurologic disorders
- contraindication to computerized activities
- blindness or severe visual impairments
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Group A ( verum tRNS + NF)
Participants allocated to this group will receive 12 sessions of intervention for the cognitive rehabilitation of attentional deficits.
The intervention will include 10 minutes of tRNS stimulation in the 16-25 Hz range and then 20 minutes of Neurofeedback training positively reinforcing 16-25 Hz (beta) and negatively reinforcing 4-7 Hz (theta).
tRNS has the followign characteristics: intensity of 1000 µA (±, 2000 µA peak-to-peak); white noise, band-pass 16-25 Hz.
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The 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 |
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가짜 비교기: Group B (sham tRNS + NF)
Participants allocated to this group will receive 12 sessions of intervention for the cognitive rehabilitation of attentional deficits.
The intervention will include 10 minutes of tRNS sham stimulation with a 30 seconds ramp up and ramp down and then 20 minutes of Neurofeedback training positively reinforcing 16-25 Hz (beta) and negatively reinforcing 4-7 Hz (theta).
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The 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Behavioral effectiveness of tRNS + NF on attention measures - CCPT
기간: 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)
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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
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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)
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Behavioral effectiveness of tRNS + NF on attention measures - Digit Span
기간: 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)
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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
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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)
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Behavioral effectiveness of tRNS + NF on attention measures - D2-R
기간: 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)
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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.
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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)
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electrophysiological effectiveness of tRNS+ NF - EEG power and connectivity
기간: 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)
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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).
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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)
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electrophysiological effectiveness of tRNS + NF - P300 ERP
기간: The P300 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)
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The P300 is a component of an event-related potential (ERP), which is a measurable brain response to a specific stimulus.
It typically occurs around 300 milliseconds after the presentation of a stimulus that is unexpected, infrequent, or relevant.
It is often used in cognitive neuroscience to study attention and decision-making processes.
It is detected using EEG and often uses tasks like the "oddball paradigm," where subjects are asked to detect infrequent target stimuli among frequent non-targets, to elicit the P300 response.
P300 will be assessed with an auditory oddball paradigm built using Eprime and Brain Vision EEG system.
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The P300 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)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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일상 생활과 인식 된 효과 - pgic
기간: PGIC 설문지는 개입 후 참가자에게 제공됩니다 (치료 종료 후 3 주 이내)
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환자의 전 세계 변화에 대한 인상은 증상과 관련된 환자의 변화에 대한 인식에 대한 두 가지 질문으로 구성된 짧은 설문지입니다.
하나의 질문은 1 ~ 7 (리 커트 스케일)이며 다른 질문은 0 ~ 10입니다.
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PGIC 설문지는 개입 후 참가자에게 제공됩니다 (치료 종료 후 3 주 이내)
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Motivation of tRNS + NF training compared to standard cognitive rehabilitation
기간: The IMI questionnaire will be filled in at T1 (post-intervention, within 3 weeks of the end of the treatment)
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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.
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The IMI questionnaire will be filled in at T1 (post-intervention, within 3 weeks of the end of the treatment)
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Side effects and adverse events of the intervention
기간: This information will be collected in the case report form during and after each session
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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).
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This information will be collected in the case report form during and after each session
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 26일
기본 완료 (추정된)
2027년 10월 1일
연구 완료 (추정된)
2027년 10월 1일
연구 등록 날짜
최초 제출
2026년 9월 7일
QC 기준을 충족하는 최초 제출
2026년 9월 11일
처음 게시됨 (실제)
2026년 9월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 11일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NeMoRe_Phase_II
- CIAPOS/2024/207 (기타 보조금/기금 번호: GENERALITAT VALENCIANA)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Outcome and demographical/clinical data will not be made openly available as it is sensitive data and cannot be shared on open access unrestricted platforms.
This is for legal reasons due to the fact that data might allow patient's identity to be revealed.
Behavioural and raw EEG data (without any demographical and clinical information) might be shared with other scientists privately on platforms such as ResearchGate upon reasonable requests.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .