Effect of Transcranial Random Noise (tRNS) for Early Alzheimer's Disease

NCT05891444 | Unknown

• 1 other identifier: AHMU-TRNS-AD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the treatment effect of Transcranial random noise (tRNS) on Alzheimer patients, and the underlying neural mechanism by EEG.

Conditions

Transcranial Random Noise; Electroencephalography; Alzheimer Disease

Keywords

Transcranial random noise; electroencephalography; Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Alzheimers Disease Assessment Scale Cognitive section(ADAS-Cog)

  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.

  baseline, 2 weeks and 8 weeks after treatment

• Associative Memory

  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.

  baseline, 2 weeks and 8 weeks after treatment

Secondary Outcomes (12)

• The changes in MMSE(Mini Mental State Examination)

  baseline, 2 weeks and 8 weeks after treatment

• DST (Digital Span Test; Forward and Backward)

  baseline, 2 weeks and 8 weeks after treatment

• TMT (Trail Making Test)

  baseline, 2 weeks and 8 weeks after treatment

• HAMD (Hamilton Depression Scale)

  baseline, 2 weeks and 8 weeks after treatment

• HAMA (Hamilton Anxiety Scale)

  baseline, 2 weeks and 8 weeks after treatment

Study Arms (2)

Transcranial random noise-Real

ACTIVE COMPARATOR

Participants will receive real tRNS once daily for two weeks

Device: High frequency transcranial random noise

Transcranial random noise-Sham

SHAM COMPARATOR

Participants will receive sham tRNS once daily for two weeks

Device: Sham high frequency transcranial random noise

Interventions

High frequency transcranial random noise DEVICE

High frequency tRNS is described as a non-invasive form of brain stimulation that uses a low-intensity, alternating current applied directly to the head through scalp electrodes.

Transcranial random noise-Real

Sham high frequency transcranial random noise DEVICE

In the sham condition, tRNS was delivered only during the ramp-up and ramp-down periods (30s); no current was delivered during the 30-minute intervention.

Transcranial random noise-Sham

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Kai Wang, PhD

CONTACT

+86-0551-62922263; wangkai1964@126.com

Xingqi Wu, PhD

CONTACT

+8618134516380; wuxingqi09@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of medical psychological department, Anhui Medical University

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: June 7, 2023
• Study Start: June 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)