Neuromodulation Therapy for Task-Specific Dystonia

NCT ID: NCT06422104

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-23
• Study Completion Date: 2023-01-13

Brief Summary

This study aims to apply a non-invasive brain stimulation technology called repetitive Transcranial Magnetic Stimulation (rTMS) in patients with focal hand dystonia (FHD). The goal of the study is to identify which cortical target (premotor cortex (PMC) or primary somatosensory cortex (PSC)) will show benefit after active rTMS compared to sham rTMS. A secondary goal of the study is to understand if 10 Hz rTMS can show behavioral benefit compared to sham rTMS. The study will evaluate rTMS response using measures if writing on a sensor tablet, examiner and patient dystonia rating scales and brain imaging scan (functional MRI) to understand brain changes after rTMS. Safety measures include adherence to TMS guidelines and thorough medical screening to prevent seizures.

Detailed Description

The primary objective of this study is to develop rTMS for FHD. The focus is to assess whether stimulating the PMC or PSC will show greater improvement in writing behavior. This research builds upon prior studies that have demonstrated improvement in behavior after rTMS to PMC and PSC. The study includes five sequential visits:

• Visit 1 behavior writing measures and dystonia rating scales.
• Visit 2 includes task-based functional MRI brain scans to develop cortical target for rTMS sessions.
• Visits 3, 4, and 5: FHD participants receive 10 Hz rTMS to PMC, PSC and sham rTMS to PMC in a cross over design with at minimum one week of washout between sessions. Participants complete behavior writing measures and rating scales on same day before and after each TMS session and an fMRI after each TMS session. Up to 5 Healthy Volunteers were recruited to help develop the TMS visits.

The information in this record reflects Visits 2-5

Conditions

Isolated Focal Hand Dystonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

10 Hz rTMS to premotor cortex

10 Hz rTMS to premotor cortex

Group Type: ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

10 Hz repetitive TMS will be delivered for 20 minutes per session and 0.7 Hz for 20 minutes per session

10 Hz rTMS to primary somatosensory cortex

10 Hz rTMS to primary somatosensory cortex

Group Type: ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

10 Hz repetitive TMS will be delivered for 20 minutes per session and 0.7 Hz for 20 minutes per session

0.7 Hz rTMS to premotor cortex

0.7 Hz rTMS to premotor cortex

Group Type: ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

10 Hz repetitive TMS will be delivered for 20 minutes per session and 0.7 Hz for 20 minutes per session

Interventions

Repetitive transcranial magnetic stimulation

10 Hz repetitive TMS will be delivered for 20 minutes per session and 0.7 Hz for 20 minutes per session

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy Control Participants:

1. 18yrs and older

2. Left or Right hand dominance

3. Age-matched to Focal Hand dystonia patients

4. Must be able to sign informed consent

5. Must be literate

• Focal Hand dystonia Patients:

1. 18yrs and older

2. Left or Right hand dominance

3. Diagnosed with Writer's Cramp dystonia in left or right hand

4. Must be able to sign informed consent

5. Must be literate

Exclusion Criteria

Healthy Control Participants (visits 2, 3, 4, and 5) and Focal Hand dystonia Patients (visits 2, 3, 4, and 5):

1. Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor

2. Botulinum toxin injections within 3 months of research study

3. Medications with effects on the central nervous system including anticholinergic, benzodiazepines, and muscle relaxants among others within 1 week of the study

4. No physical or occupational therapy of the upper extremities

5. Any contraindications to MRI (ie: metal in body or implanted medical devices, etc)

6. Any contraindication on TMS adult safety screening (TASS form) including seizure history, pregnancy, brain injury, cranial metal implants, known structural brain lesion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Doris Duke Charitable Foundation

OTHER

Sponsor Role: collaborator

Dystonia Coalition

OTHER

Sponsor Role: collaborator

Dystonia Study Group

OTHER

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noreen Bukhari-Parlakturk, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

Duke University Health System

Durham, North Carolina, United States

Countries

United States

References

Mulcahey PJ, Peterchev AV, Calakos N, Bukhari-Parlakturk N. Transcranial magnetic stimulation: the road to clinical therapy for dystonia. Dystonia. 2023 August; 2.

Reference Type: BACKGROUND

Bukhari-Parlakturk N, Mulcahey PJ, Lutz M, Ghazi R, Huang Z, Dannhauer M, Simsek Z, Groves S, Lipp M, Fei M, Tran T, Wood E, Beynel L, Scott B, Termsarasab P, Petty C, Al-Khalidi HR, Voyvodic J, Appelbaum LG, Davis S, Michael A, Peterchev AV, Calakos N. Functional MRI-guided personalized TMS decreases basal ganglia activity and improves focal hand dystonia. International Organization of Human Brain Mapping Conference. Montreal, Canada. July 22-26, 2023. virtual poster presentation.

Reference Type: BACKGROUND

Bukhari-Parlakturk N, Mulcahey PJ, Lutz M, Ghazi R, Huang Z, Dannhauer M, Simsek Z, Groves S, Lipp M, Fei M, Tran T, Wood E, Beynel L, Scott B, Termsarasab P, Petty C, Al-Khalidi HR, Voyvodic J, Appelbaum LG, Davis S, Michael A, Peterchev AV, Calakos N. Functional MRI-guided personalized TMS decreases basal ganglia activity and improves focal hand dystonia. International Dystonia Symposium. Dublin, Ireland. June 1-3, 2023. poster presentation.

Reference Type: BACKGROUND

Bukhari-Parlakturk N, Lutz MW, Al-Khalidi HR, Unnithan S, Wang JE, Scott B, Termsarasab P, Appelbaum LG, Calakos N. Suitability of Automated Writing Measures for Clinical Trial Outcome in Writer's Cramp. Mov Disord. 2023 Jan;38(1):123-132. doi: 10.1002/mds.29237. Epub 2022 Oct 13.

Reference Type: BACKGROUND

PMID: 36226903 (View on PubMed)

Dannhauer M, Huang Z, Beynel L, Wood E, Bukhari-Parlakturk N, Peterchev AV. TAP: targeting and analysis pipeline for optimization and verification of coil placement in transcranial magnetic stimulation. J Neural Eng. 2022 Apr 21;19(2):10.1088/1741-2552/ac63a4. doi: 10.1088/1741-2552/ac63a4.

Reference Type: BACKGROUND

PMID: 35377345 (View on PubMed)

Other Identifiers

Pro00094131

Identifier Type: -

Identifier Source: org_study_id