Recruiting

Theta DBS

Sponsor:

University of British Columbia

Code:

NCT06518824

Conditions

Parkinson Disease

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

DBS On

DBS Off

Study Details

Brief summary:

Cognitive impairment is common in Parkinson's disease. A recent study demonstrated 40% of people with PD suffer from mild cognitive impairment and > 80% of patients develop dementia after a disease duration of 20 years. Cognitive impairment significantly impairs quality of life and has limited treatment options. While the pathophysiology of cognitive symptoms in PD is multifactorial, one contributing factor is dysfunction in subthalamic-cortical loops.

The subthalamic nucleus (STN) receives input from distributed regions of the cortex, forming partially segregated parallel networks with sensorimotor regions, associative (cognitive) cortical regions, and limbic cortical regions. These subthalamic-cortical networks are thought to play a domain general role in inhibitory control, which is a fundamental mechanism underlying flexible behavior across motor, cognitive, and affective domains. Information processing in these subthalamic-cortical networks is expressed through oscillatory activity within distinct frequency bands. For example, communication between the STN and prefrontal regions involved in executive function is thought to occur through coherence in the theta (4-8 Hz) frequency band. As a result of these observations, stimulation of the STN at a theta frequency has been investigated as a method of modulating cognitive processes.

Theta stimulation of the STN has been shown to enhance coherence in subthalamic-cortical networks, facilitating information processing and modulating behavior. For example, a recent study demonstrated that theta stimulation of the STN improved working memory performance in PD subjects, while no effect was seen for other frequency bands. The authors performed a post-hoc analysis and found that the effect may be mediated by connectivity between the stimulated STN region and the right dorsolateral prefrontal cortex (DLPFC). While these studies have demonstrated proof of principle, they are limited by small sample sizes and post-hoc analyses assessing the relationship between stimulation location and outcomes. Further research is needed to directly test the hypothesis that theta stimulation of the STN can improve executive control in PD patients by modulating associative STN circuitry.

Conditions

Parkinson Disease

Cognitive Impairment

Study ID

NCT06518824

Start date

Dec, 2024

Status verified date

Nov, 2024

Completion date

Oct, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Those with STN DBS devices
  • Those with pre- and post-operative imaging
  • Those that are at least 3 months post-operative

Exclusion Criteria:

  • Those unable to complete the cognitive task (due to language barriers or dementia)
  • Those with significant DBS complications

Study Design

Enrollment

27 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Stimulation off

The deep brain stimulation device will be turned off.

experimental: Theta stimulation of associative STN region

The deep brain stimulation device will be set to a frequency of 6 Hz and will stimulate the associative STN region. If differential activation of the associative and sensorimotor STN networks is not feasible, ventral stimulation is employed.

active comparator: Theta stimulation of STN sensorimotor region

The deep brain stimulation device will be set to a frequency of 6 Hz and will stimulate the sensorimotor region, acting as an anatomical control. If differential activation of the associative and sensorimotor STN networks is not feasible, dorsal stimulation is employed.

active comparator: High frequency stimulation of associative STN region

The deep brain stimulation device will be set to a frequency of 135 Hz and will stimulate the associative STN region, acting as a frequency control. If differential activation of the associative and sensorimotor STN networks is not feasible, ventral VTA is employed.

Interventions

DBS On

The DBS device will be turned on while the patient undergoes the working memory task.

DBS Off

The DBS device will be turned off while the patient undergoes the working memory task.

Primary outcome measure

  • Change in working memory performance between conditions [ Time Frame: Immediately after task performance ]

Central Contacts and Locations

Central contacts

Locations

Leslie and Gordan Diamond Health Care Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Stefan Lang, MD PhD FRCSC

604-875-5540stefan.lang@vch.ca

More Information

Sponsor

University of British Columbia

Last update posted

Nov 25, 2024

Last verified

Nov, 2024

Keywords

  • Theta Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-11-25.