rTMS and Botulinum Toxin in Primary Cervical Dystonia
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 30 - 75 |
| Updated: | 8/26/2018 |
| Start Date: | November 2015 |
| End Date: | September 2019 |
| Contact: | Aparna Wagle-Shukla, M.D. |
| Email: | aparna.shukla@neurology.ufl.edu |
| Phone: | 352-294-5400 |
Combined Therapy With rTMS and Botulinum Toxin in Primary Cervical Dystonia
Primary cervical dystonia (PCD) is the most common form of focal dystonia. PCD is frequently
reported as a source of disability, decreased quality of life, and social stigma. Botulinum
toxin (BoNT) is the gold standard treatment for PCD. The average duration of benefits from
BoNT injections was about 9.5 weeks and BoNT treatment is known to provide only pure
symptomatic benefits and does not seem to modify the disease pathophysiology.
The investigator plans to use repetitive transcranial magnetic stimulation (rTMS) therapy as
an adjunctive therapy in combination with BoNT injections as a novel approach to treat PCD.
The primary goal of this study is to compare standard treatment with BoNT versus BoNT
combined with a two week course of rTMS.
reported as a source of disability, decreased quality of life, and social stigma. Botulinum
toxin (BoNT) is the gold standard treatment for PCD. The average duration of benefits from
BoNT injections was about 9.5 weeks and BoNT treatment is known to provide only pure
symptomatic benefits and does not seem to modify the disease pathophysiology.
The investigator plans to use repetitive transcranial magnetic stimulation (rTMS) therapy as
an adjunctive therapy in combination with BoNT injections as a novel approach to treat PCD.
The primary goal of this study is to compare standard treatment with BoNT versus BoNT
combined with a two week course of rTMS.
rTMS refers to the application of transcranial magnetic stimulation (TMS) pulses to a
specific target at predefined stimulation parameters. Repeated sessions of rTMS therapy have
been demonstrated to induce cumulative persistent benefits that can last weeks after the
conclusion of the rTMS sessions
The central hypothesis of this study is that rTMS therapy in PCD can potentiate the effects
of BoNT injections. With the current standard treatment, the peak-dose benefits seen with
BoNT are seen at about 4-6 weeks after the administration of injections. The investigator
will introduce a 1 week course of rTMS around 2-8 weeks before or after BoNT or T1). The
investigator will examine the effects of combined therapy at 10 weeks after BoNT and 12 weeks
after BoNT injections follow-up.
specific target at predefined stimulation parameters. Repeated sessions of rTMS therapy have
been demonstrated to induce cumulative persistent benefits that can last weeks after the
conclusion of the rTMS sessions
The central hypothesis of this study is that rTMS therapy in PCD can potentiate the effects
of BoNT injections. With the current standard treatment, the peak-dose benefits seen with
BoNT are seen at about 4-6 weeks after the administration of injections. The investigator
will introduce a 1 week course of rTMS around 2-8 weeks before or after BoNT or T1). The
investigator will examine the effects of combined therapy at 10 weeks after BoNT and 12 weeks
after BoNT injections follow-up.
Inclusion Criteria:
- Diagnosis of PCD in accordance with the Consensus Statement of the Movement Disorder
Society
- Subjects who report Botulinum Toxin benefits lasting 10 weeks or less only (suboptimal
benefits with standard care)
Exclusion Criteria:
- Pregnancy
- Active seizure disorder
- Presence of a metallic body such as pacemaker, implants, metal rods and hearing aid.
We found this trial at
2
sites
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Gainesville, Florida 32607
Principal Investigator: Aparna Shukla, MD
Phone: 352-273-5566
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