Mild non-invasive brain stimulation for apathy in Huntington's disease

Not Applicable

Completed

• Conditions: Huntington's disease; Apathy; Neurological - Other neurological disorders; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

• Registration Number: ACTRN12619000870156
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-19
• Study Completion: 2021-08-02
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Individuals with genetically confirmed prodromal or early stage HD, as well as individuals without HD matched for age, gender and education will be sought as participants.
-Participants with prodromal HD will need to be within approximately 12 years of expected motor onset or have a disease burden score” (DBS) of at least 280, indices calculated using the prospective participant’s current age and number of CAG repeats on the affected allele.
-Participants with early stage manifest HD will need to have a total functional capacity (TFC) score greater than, or equal to 10 . The TFC is used to assess how much assistance a person with HD requires to perform tasks in five functional domains that decline with disease progression (i.e., occupation, finances, domestic chores, activities of daily living, and care level).

Exclusion Criteria

- Use of anticonvulsant medications or regular treatment with benzodiazepines (versus limited as-needed use, with none consumed within the 48 hours prior to an experimental session).
-Commencement or significant dosage alteration of other psychotropic medications (i.e., anti-depressants, anti-psychotics) during the four weeks prior to an experimental session.
-Choreiform movements that preclude tACS or EEG data collection.
-A current episode of psychiatric illness, or a current substance use or alcohol use disorder, initially assessed via the recruitment screen, and then as assessed and defined by the Mini International Neuropsychiatric Interview (MINI) 7.0.2.
-Any history of significant head injury or traumatic brain injury, as defined by a loss of consciousness greater than 30 minutes or requiring a hospital admission.
-Unstable medical illness.
-Pregnancy or breastfeeding.
-An uncorrected hearing or visual impairment (including difficulty with colour perception).
-Significant difficulties with understanding or communicating in English.
-Metallic implants within the head, a pacemaker, cochlear implant, medication pump or other electronic device within the body.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in resting power on electroencephalogram (EEG).[Resting eyes closed and eyes open EEG measured immediately before and immediately after each stimulation condition. ];Changes in event-related EEG activity during completion of the Monetary Incentive Delay (MID) task.[The MID task completed immediately before and immediately after each stimulation condition. ]

Secondary Outcome Measures

Name	Time	Method
Total score on the Apathy Evaluation Scale Clinician version (AES-C).[Baseline/session 1.]