Plasticity of Deep Brain Structures in Mild Cognitive Impairment and Healthy Aging (PlasMA)

Friedhelm Hummel

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Other: transcranial electric stimulation

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06822283

2020-00127

Details and patient eligibility

About

Acute and chronic cognitive impairment (TBI and MCI) is one of the most common problems in the growing and aging society of the 21st century. At an individual level, not all brain structures are affected with the same rate. There are subcortical structures less involved (e.g., the cerebellum), and other more involved (e.g., the hippocampus) in the cognitive decline with age or following a traumatism. To pave the way for personalized precision medicine in the field of cognitive preservation and recovery, there is a need for testing the impact of individually tailored innovative non-invasive neuro-technologies. In this project, we aim at testing the benefit of non-invasively stimulating subcortical structures to boost resilience in supporting motor and non-motor memory.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

TBI patients:

• Age ≥ 18 years
• Clinical diagnosis of TBI
• No history of other severe neurological or psychiatric disorders

Exclusion criteria

• Unable to consent

  • Severe neuropsychiatric (e.g., major depression, severe dementia) or unstable systemic diseases (e.g., severe progressive and unstable cancer, life threatening infectious diseases)

  • Severe sensory or cognitive impairment or musculoskeletal dysfunctions prohibiting to understand instructions or to perform the experimental tasks

  • Inability to follow or non-compliance with the procedures of the study

  • Contraindications for NIBS or MRI (1):

    • Electronic or ferromagnetic medical implants/device, non-MRI compatible metal implant
    • History of seizures
    • Medication that significantly interacts with NIBS being benzodiazepines, tricyclic antidepressants and antipsychotics

  • Regular use of narcotic drugs

  • Pregnancy

  • Request of not being informed in case of incidental findings

  • Concomitant participation in another trial involving probing of neuronal plasticity

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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19 participants in 2 patient groups, including a placebo group

Placebo stimulation

Placebo Comparator group

Description:

Sham stimulation : ramp-up \[5 s\] immediately followed by ramp-down \[5 s\] of high-frequency currents (see Vassiliadis et al., 2023, Nat Hum Behav for more details)

Treatment:

Other: transcranial electric stimulation

Active stimulation

Experimental group

Description:

Patterned stimulation (intermittent theta-burst) generating temporal interference in the striatum; see Wessel et al., 2023, Nat Neurosci. for details

Treatment:

Other: transcranial electric stimulation