Transcranial Random Noise (tRNS) for BPSD in Alzheimer's Disease: A Double-blind Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-84
SponsorAnhui Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Transcranial random noise-RealActive comparator 1 intervention
Group B: Transcranial random noise-ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

1. 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.

Time frame
baseline, 2 weeks and 8 weeks after treatment

Secondary outcomes

1

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.

Time frame
baseline, 2 weeks and 8 weeks after treatment

Other outcomes

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