Transcranial Random Noise (tRNS) for BPSD in Alzheimer's Disease: A Double-blind Randomized Controlled Trial
Transcranial Random Noise (tRNS) for Behavioral and Psychological Symptoms in Alzheimer's Disease (BPSD): A Randomized, Double-blind, Sham-Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Description détaillée
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after Transcranial random noise (tRNS) treatment. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and tRNS treatments at the First Affiliated Hospital of AnHui medical university. Patients were randomly allocated to tRNS group and the sham group. There are about 20 patients in each group. For the all patients, allocation was by coin toss. Patients were studied using a double-blind design. Study participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only tRNS administrators had access to the randomization list; they had minimal contact with the patients, and no role in cognitive and synptom assessments. Each patient would be treated for continuous 14 days by tRNS. The stimulation electrodes were arranged in a 4 × 1 ring at AFz, FCz, F7, C5 and F3, with the central electrode producing a random alternating current of 1.5ma and the surrounding 4 electrodes producing 1/4 of the current of the central electrode. At 100-640 Hz tRNS, participants had a mean interpeak-to-peak stimulation intensity of 1.5mA. Under the sham conditions, 100-640 Hz tRNS were delivered only during the ascent and descent phases (30 seconds); No current was transmitted during the 30-minute intervention. The tRNS stimulation lasted for 30 minutes, which is common in cognitive neuroscience research.
Before the tRNS treatment, a series of cognitive assessments and neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the associative memory as the primary outcome measure and various other tasks and questionnaires to measure cognition(including MoCA,MMSE, DS, Stroop test, TMT, BNT-30, VFT, CDT,JLOT. Form H,HVOT), memory (CAVLT, LMT), emotion(HAMA-17,HAMD-14,GDS-30), behavioral and psychological symptoms(NPI), and treatment tolerability. All the tests are conducted in two days. The patient received resting EEG data collection. After the last treatment, the MoCA, and associative memory were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, resting EEG. Two month after the last treatment, participants were interviewed to obtain the same assessment as before. They were instructed to focus their answers on the past months.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kai Wang, PhD
- Numéro de téléphone: +86-0551-62922263
- E-mail: wangkai1964@126.com
Sauvegarde des contacts de l'étude
- Nom: Xingqi Wu, PhD
- Numéro de téléphone: +8618134516380
- E-mail: wuxingqi09@163.com
Lieux d'étude
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Anhui
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Hefei, Anhui, Chine, 230032
- Recrutement
- Anhui Medical University, Hefei, Anhui 230032
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Contact:
- Xinyu Shi
- Numéro de téléphone: 86+19105529199
- E-mail: 2819027557@qq.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
- Subjects must have a MMSE score between 10 and 27,indicating mild cognitive impairment or dementia
- CDR score ≤ 2
- Subject under treatment by IAChE for at least 3 months.
- psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months
Exclusion Criteria:
- NPI ≥ 4
- CDR > 2
- Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
- History of head injury,stroke,or other neurologic disease.
- Organic brain defects on T1 or T2 images.
- History of seizures or unexplained loss of consciousness.
- Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator.
- Family history of medication refractory epilepsy.
- History of substance abuse within the last 6 months.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Bruit aléatoire transcrânien-réel
Les participants recevront du vrai tRNS une fois par jour pendant deux semaines
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Le tRNS à haute fréquence est décrit comme une forme non invasive de stimulation cérébrale qui utilise un courant alternatif de faible intensité appliqué directement sur la tête via des électrodes du cuir chevelu.
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Comparateur factice: Transcranial random noise-Sham
Arm Description: Participants will receive sham tRNS once daily for two weeks
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Dans la condition simulée, le tRNS n'a été délivré que pendant les périodes de montée et de descente (30 s) ; aucun courant n'a été délivré pendant l'intervention de 30 minutes.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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1. Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)
Délai: baseline, 2 weeks and 8 weeks after treatment
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The changes in Alzheimers Disease Assessment Scale Cognitive section (ADAS-Cog) will constitute the major research outcome measure used to assess response to Transcranial Random Noise (tRNS).
The ADAS-Cog scale is a scale used for clinical assessment of dementia patients with some memory efficiency tests, which can be used as an objective assessment of memory.
The scale is considered a tool capable of providing a specific assessment of the severity of cognitive and non-cognitive behavioral impairments in people with Alzheimer's disease or dementia.
The advantage of the ADAS-Cog compared to other scales used in the same clinical area is that its score quantifies clinical and impressionistic aspects of the patient assessed by the examiner, as well as objectively defined cognitive characteristics.
The higher the ADAS-Cog score, the worse the cognitive function.
The minimum value is 0 and the maximum is 86.
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baseline, 2 weeks and 8 weeks after treatment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Associative Memory
Délai: baseline, 2 weeks and 8 weeks after treatment
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The changes in Associative Memory will constitute the major research outcome measure used to assess response to tRNS.
The associative memory test uses facial cue word recall.
The subjects memorized 20 photos of faces displayed on a screen in gray scale for 4 seconds each.
When each card was presented, a common word appeared alongside the face.
The subjects had to remember associations between faces and words by association.
After a delay of about a minute after the study ended, the subjects were shown 12 of the same faces in different random orders, instructing them to recall the words that appeared with each face during the study.
Recorded the correct number of words each face recalled.
The faces were taken from a database of 24 amateur models.
Each test format included only male or female faces.
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baseline, 2 weeks and 8 weeks after treatment
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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AHMU-TRNS--BPSD
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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