Brain and Behavioral Influences on Motor Skill Learning in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT03404388
• Date of registration: 11/01/2018
• Prospective Registration: Yes
• Primary sponsor: Wayne State University
• Public title: Brain and Behavioral Influences on Motor Skill Learning in Multiple Sclerosis
• Scientific title: Brain and Behavioral Influences on Motor Skill Learning in Multiple Sclerosis
• Date of first enrolment: April 1, 2020
• Target sample size: 150
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/ct2/show/NCT03404388
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of Relapsing-Remitting MS,

2. Patient Determined Disease Steps (PDDS) <6.5, indicating ability to ambulate with or
without an assistive device (Hohol, 1999; Learmonth, 2013)

3. between the ages of 18 and 65;

4. stable medication regime for 3 months prior to enrollment, and

5. able to follow study-related commands.

Exclusion Criteria:

1. history of other neurological or neuromuscular conditions,

2. acute orthopedic conditions that prevent participation in the training,

3. steroid use <30 days prior to enrollment;

4. history of alcohol abuse;

5. presence of metallic implants, medical implants or exposure to metallic shrapnel
incompatible with MRI,

6. pregnancy;

7. history of hospitalization for depression; and

8. depression as evidenced by a score of =10 on the Patient Health Questionnaire-9
(PHQ-9) (Kroenke, 2001), as depression has been shown to impact motor learning in
persons with neurologic disorders (Subramanian, 2015).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Behavioral: Balance Training

Primary Outcome(s)

Change in Dual-Task Cost [Time Frame: Outcome will be assessed at baseline visit and post-test visit (1 week later)]

Secondary Outcome(s)

Objective Balance Control [Time Frame: Outcome will be assessed at baseline visit and post-test visit (1 week later)]

Berg Balance Scale [Time Frame: Outcome will be assessed at baseline visit and post-test visit (1 week later)]

Secondary ID(s)

122415M1E

Source(s) of Monetary Support

Please refer to primary and secondary sponsors