NCT06984757

Mid-frontal Delta/Theta and Cognitive Control

ENROLLING BY INVITATION NA Last updated 22 May 2025

What this trial tests

NA trial testing Deep-brain Stimulation in Parkinson&Amp;Amp;#39;s Disease (PD) in 635 participants. Enrolling by invitation.

Timeline

25 September 2017

Primary endpoint
31 December 2029

31 December 2029

Quick facts

Lead sponsor	Nandakumar Narayanan
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	non randomized
Design	factorial
Masking	single
Primary purpose	basic science
Enrollment	635
Start date	25 September 2017
Primary completion	31 December 2029
Estimated completion	31 December 2029
Sites	1 location across United States

Drugs / interventions tested

• Deep-brain Stimulation
• Transcranial Magnetic Stimulation — full drug profile →
• Transcranial Alternating Current Stimulation

Conditions studied

• Parkinson&Amp;Amp;#39;s Disease (PD) — all drugs for Parkinson&Amp;Amp;#39;s Disease (PD) →

Sponsor

Nandakumar Narayanan — full company profile →

Who can join

Adults 18 to 99, any sex, with Parkinson&Amp;Amp;#39;s Disease (PD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Abstract Cognitive symptoms of Parkinson's disease (PD) include deficits in attention, working memory, and reasoning. These deficits affect up to 80% of PD patients and lead to mild cognitive impairment (PD-MCI) and dementia in PD (PDD). There is a critical need to better understand cognitive impairment in PD to develop new targeted treatments. The long-term goal is to define the mechanisms of PD-related cognitive impairment. PD involves diverse processes such as dopamine and acetylcholine dysfunction, synuclein aggregation, and genetic factors. During the past funding period, the investigators linked PD-related cognitive impairment to dysfunction in frontal midline delta (1-4 Hz) and theta (5-7 Hz) rhythms, which the work has established as a marker of cognitive control. However, it is unknown why PD patients have deficits in these low-frequency brain rhythms. The preliminary magnetic resonance imaging (MEG) and magnetoencephalography (MRI) implicate the anterior midcingulate cortex (aMCC) as a potential source of frontal midline delta/theta rhythms. In the next funding period, the objective is to determine the mechanisms and predictive power of delta/theta rhythms in PD, which will help to better understand the pathophysiology of PD-related cognitive impairment. Collaboration between the University of New Mexico (UNM) and University of Iowa (UI) that will bring together MEG, MRI, longitudinal EEG, and adaptive subthalamic (STN) deep-brain stimulation (DBS). The investigators will test the overall hypothesis that frontal midline delta/theta dysfunction contributes to cognitive impairments in PD. In Aim 1, the investigators will determine the structural basis for delta/theta rhythm deficits in PD. In Aim 2, the investigators will determine the predictive power of delta/theta rhythm deficits in PD. In Aim 3, the investigators will determine how tuned low-frequency STN DBS impacts cortical activity and cognition. The results will have relevance for basic-science knowledge of the fundamental pathophysiology of cognitive impairment in PD and related dementias. Because this proposal will study patients with PDD, the findings are directly relevant to Alzheimer's-related dementias (ADRD).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.