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Behavioural Intervention

Neurostimulation for Mild Cognitive Impairment (PAS-MCI Trial)

N/A
Recruiting
Led By Tarek Rajji, MD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of MCI due to AD using the core clinical criteria by the National Institute on Aging and Alzheimer's Association for MCI participants and ascertained by a study investigator.
Current anticonvulsant use due to its impact on TMS induced activity and ascertained using a Medication List. An exception will be made if they are taking gabapentin or pregabalin AND if the dose had been stable for at least 4 weeks prior to study entry AND if prescribed for chronic pain.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

PAS-MCI Trial Summary

This trial is testing a neurostimulation approach to see if it can enhance prefrontal cortical plasticity and function in patients with MCI, in an effort to find a treatment modality that could potentially prevent progression to AD.

Who is the study for?
This trial is for right-handed individuals aged 60 or above with Mild Cognitive Impairment (MCI) due to Alzheimer's, who can communicate in English and have a MoCA score over 26. They should not be demented, nor have cognitive decline from vascular, traumatic, or medical causes. Participants must not use certain psychotropic medications or high doses of benzodiazepines and cannot have contraindications to MRI or TMS.Check my eligibility
What is being tested?
The study tests Paired Associative Stimulation (PAS), a neurostimulation technique aimed at enhancing the plasticity of the prefrontal cortex in patients with MCI. The goal is to improve brain function and potentially prevent progression to Alzheimer's dementia by strengthening compensatory mechanisms.See study design
What are the potential side effects?
While specific side effects are not listed here, PAS generally may cause discomfort at the stimulation site, headache, lightheadedness, or temporary changes in brain activity patterns which could affect cognition.

PAS-MCI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with mild cognitive impairment due to Alzheimer's.
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I am on anticonvulsants for chronic pain, with a stable dose for 4 weeks.
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I am 60 years old or older.
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I take more than 2 mg/day of a medication similar to lorazepam.
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I am currently taking medication for a brain or nerve condition.
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I have been diagnosed with mild cognitive impairment due to Alzheimer's disease.
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I am 60 years old or older.
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I have been diagnosed with mild cognitive impairment due to Alzheimer's.
Select...
I am 60 years old or older.

PAS-MCI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately and 1 and 4 weeks following the 10-session course
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately and 1 and 4 weeks following the 10-session course for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in N-Back Performance
Change in PAS-Long-term-potentiation (PAS-LTP)
N-Back Performance
+1 more
Secondary outcome measures
Change in Executive Function Composite Measure
Executive Function Composite Measure

PAS-MCI Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Healthy ControlActive Control1 Intervention
Healthy Controls will complete screening and baseline N-Back and PAS-EEG. They will not complete the 10-session course of PAS or follow-up assessments.
Group II: Active PASActive Control1 Intervention
After completing the N-back and PAS-EEG at Visit 4, MCI participants randomized to the active condition will receive a 10-session course of PAS (Visits 5-14), followed by the three follow-up assessments at 0 days, 7 days, and 28 days post intervention.
Group III: PAS-Control (PAS-C)Placebo Group1 Intervention
After completing the N-back and PAS-EEG at Visit 4, MCI participants randomized to the sham condition will receive a 10-session course of PAS-C (Visits 5-14), followed by the three follow-up assessments at 0 days, 7 days, and 28 days post intervention.

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
351 Previous Clinical Trials
80,666 Total Patients Enrolled
Tarek Rajji, MDPrincipal InvestigatorCentre for Addiction and Mental Health
5 Previous Clinical Trials
471 Total Patients Enrolled

Media Library

Paired Associative Stimulation (PAS) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04583215 — N/A
Mild Cognitive Impairment Research Study Groups: PAS-Control (PAS-C), Healthy Control, Active PAS
Mild Cognitive Impairment Clinical Trial 2023: Paired Associative Stimulation (PAS) Highlights & Side Effects. Trial Name: NCT04583215 — N/A
Paired Associative Stimulation (PAS) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04583215 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals will be included in the research project?

"Affirmative. According to the clinicaltrials.gov, this study is currently enrolling participants with a first posting date of October 12th 2020 and most recent update as August 9th 2022. The trial needs 150 patients at one site for completion."

Answered by AI

Are any enrollees being accepted for this experiment presently?

"That is correct. Clinicaltrials.gov states that this clinical trial, originally posted on October 12th 2020, is actively seeking volunteers. 150 individuals are required to be enrolled from a single medical centre."

Answered by AI
~63 spots leftby Oct 2026