Phase 2
N=9
rTMS and Retraining in Focal Hand Dystonia
Focal Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT01738581 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Change From Baseline in Global Rating of Change at Posttest (Day 5) — 1.3; 1.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Repetitive Transcranial Magnetic Stimulation (Device); Sensorimotor Retraining (Behavioral); Non-specific Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Global Rating of Change at Posttest (Day 5) |
1.3; 1.2 | — |
| SECONDARY Change From Baseline in Arm Dystonia Disability Scale at Posttest (Day 5) |
71.98; 71.42 | — |
| SECONDARY Change From Baseline in Sensation at Posttest (Day 5) |
3; 2; 2; 1; 0; 1 | — |
| SECONDARY Change From Baseline in Cortical Silent Period at Posttest (Day 5) |
2; 1; 2; 1; 1; 2 | — |
| SECONDARY Change From Baseline for Pressure During Hand Writing at Posttest (Day 5) |
2; 2; 3; 1; 0; 0 | — |
| SECONDARY Change From Baseline for Physician Rated Impairment at Posttest (Day 5) |
2; 0; 3; 3; 0; 1 | — |
| SECONDARY Change From Baseline in Physical Function at Posttest (Day 5) |
1; 0; 4; 2; 0; 2 | — |
Summary
This study is exploring a new experimental procedure in dystonia called repetitive transcranial magnetic brain stimulation (TMS) combined with rehabilitation. The purpose of the study is to determine whether repetitive TMS is effective as a treatment to reduce symptoms in dystonia as demonstrated by improved motor performance.
Eligibility Criteria
Inclusion Criteria
- Greater than 18 years of age
- Symptoms of focal hand dystonia or writer's cramp
Exclusion Criteria
- History of seizure or other neurologic disorder
Data sourced from ClinicalTrials.gov (NCT01738581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.